Company · US
Zimmer, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2026. Name variants (Inc, Corp, punctuation) are merged.
423510(k) clearances (9 in 12 months)
1,073recalls (26 in 12 months)
689recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 355 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 102 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 73 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 69 |
| HWC | Screw, Fixation, Bone | 62 |
| HTW | Bit, Drill | 60 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 50 |
| LXH | Orthopedic Manual Surgical Instrument | 48 |
| HWT | Template | 46 |
| HRS | Plate, Fixation, Bone | 44 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 38 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 38 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 36 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 33 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 27 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 24 |
| JDW | Pin, Fixation, Threaded | 21 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 19 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 18 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 17 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2026 | K262955 | OsseoFit Stemless Shoulder System Zimmer, Inc. | PKC |
| Jun 16, 2026 | K261683 | Augment Off-Axis Instrument System Zimmer, Inc. | PHX |
| Jun 16, 2026 | K260831 | Z1 Hip System Zimmer, Inc. | LZO |
| May 28, 2026 | K251840 | Zimmer® Persona® Personalized Knee System Zimmer, Inc. | MBH |
| Apr 27, 2026 | K260182 | Avenir® Müller Stem; Avenir Complete Hip System Zimmer, Inc. | LZO |
| Apr 13, 2026 | K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Hume Zimmer, Inc. | MBF |
| Mar 12, 2026 | K253566 | Affixus Retrograde Femoral Nailing System Zimmer, Inc. | HSB |
| Mar 9, 2026 | K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) Zimmer, Inc. | MBH |
| Feb 4, 2026 | K252623 | G7® Revision Acetabular System Zimmer, Inc. | LPH |
| Aug 11, 2025 | K251098 | Identity Revision Humeral Stems Zimmer, Inc. | MBF |
| Jul 18, 2025 | K251906 | Z1 Hip System Zimmer, Inc. | LZO |
| Jul 2, 2025 | K250848 | Identity Shoulder System Zimmer, Inc. | MBF |
| Mar 6, 2025 | K243724 | Persona® Revision Knee System (Persona Revision SoluTion Femoral Components) Zimmer, Inc. | JWH |
| Feb 12, 2025 | K243907 | Affixus Tibial Nailing System - 4mm screws Zimmer, Inc. | HSB |
| Dec 11, 2024 | K241873 | OsseoFit Stemless Shoulder System Zimmer, Inc. | PKC |
| Nov 22, 2024 | K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) Zimmer, Inc. | MBH |
| Oct 29, 2024 | K243247 | Persona the Personalized Knee System Zimmer, Inc. | MBH |
| Sep 26, 2024 | K241651 | Affixus Tibial and Antegrade Femoral Nailing System Zimmer, Inc. | HSB |
| Jun 12, 2024 | K240876 | Identity Shoulder System Zimmer, Inc. | MBF |
| Apr 26, 2024 | K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) Zimmer, Inc. | MBH |
| Mar 8, 2023 | K230321 | Persona Personalized Knee System Zimmer, Inc. | JWH |
| Jan 10, 2023 | K211047 | CoCr Head Zimmer GmbH, CH | LPH |
| Nov 17, 2022 | K221479 | Persona Personalized Knee System Zimmer, Inc. | JWH |
| Oct 17, 2022 | K222566 | Zimmer Persona Personalized Knee System Zimmer, Inc. | MBH |
| Sep 15, 2022 | K213856 | Identity Shoulder System Zimmer, Inc. | MBF |
| Apr 28, 2022 | K212512 | G7® Vivacit-E® Freedom® Constrained Liner Zimmer, Inc. | PBI |
| Dec 10, 2021 | K210842 | VerSys Cemented Revision/Calcar Zimmer, Inc. | JDI |
| May 18, 2021 | K210829 | Persona Revision Knee System Femoral Metaphyseal Cones Zimmer, Inc. | JWH |
| Mar 18, 2021 | K210551 | Persona Revision Knee System Zimmer, Inc. | JWH |
| Dec 10, 2020 | K192798 | Zimmer Segmental System Zimmer, Inc. | KRO |
| Jul 16, 2020 | K191449 | ZCA All-Poly Acetabular Cups Zimmer, Inc. | JDI |
| Jul 9, 2020 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I Zimmer, Inc. | JDI |
| Apr 28, 2020 | K200814 | Affixus(R) Natural Nail(R) System Humeral Nail Zimmer GmbH, CH | HSB |
| Apr 10, 2020 | K200112 | Zimmer Hip Joint Replacement Zimmer GmbH, CH | LZO |
| Mar 24, 2020 | K200209 | Persona Personalized Knee System Zimmer, Inc. | JWH |
| Mar 20, 2020 | K191735 | CPT Hip System Zimmer, Inc. | JDI |
| Mar 17, 2020 | K200151 | Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Zimmer, Inc. | HSX |
| Feb 28, 2020 | K192660 | Zimmer M/L Taper Hip Prosthesis Zimmer, Inc. | LZO |
| Feb 24, 2020 | K193180 | Alliance Augmented Glenoid Zimmer, Inc. | KWS |
| Jan 29, 2020 | K193099 | Anatomical Shoulder System Zimmer GmbH, CH | PHX |
| Jan 24, 2020 | K193223 | Persona Personalized Knee System Zimmer, Inc. | JWH |
| Dec 26, 2019 | K193050 | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem Zimmer GmbH, CH | LZO |
| Dec 18, 2019 | K192189 | Avenir Complete Hip System, Size 0 Coxa Vara Zimmer, Inc. | LZO |
| Dec 6, 2019 | K193030 | Avenir Muller Stem, Avenir Cemented Hip Stem Zimmer GmbH, CH | LZO |
| Dec 6, 2019 | K190656 | Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings Zimmer, Inc. | LPH |
| Dec 5, 2019 | K190660 | G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslin Zimmer, Inc. | LPH |
| Nov 5, 2019 | K192236 | Fitmore Hip Stem Zimmer GmbH, CH | KWY |
| Nov 5, 2019 | K183457 | Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head Zimmer, Inc. | LPH |
| Oct 23, 2019 | K191814 | Alliance Glenoid Zimmer, Inc. | KWS |
| Oct 11, 2019 | K192312 | Zimmer Natural Nail System Cephalomedullary Nails Zimmer GmbH, CH | HSB |
Newest 50 of 423.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2026 | Zimmer, Inc. Brand Name: Persona Revision
Product Name: Persona Revision Trabecular Metal Femoral Distal Augment
Model/Catalog Number: 42-5572-066-10
Software Version: N/A
Product Description: Persona Revision Tra Open, Classified |
MBH | K181947 K191625 +1 |
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476 Open, Classified |
PHX | K241043 |
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444 Open, Classified |
PHX | K241043 |
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide
Model/Catalog Number: 110040242 Open, Classified |
PHX | K241043 |
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide
Model/Catalog Number: 110040241 Open, Classified |
PHX | K241043 |
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240 Open, Classified |
PHX | K241043 |
| Apr 24, 2026 | Zimmer, Inc. Brand Name: Disposable Mixing Bowls with Spatula
Product Name: Mixing Bowl and Spatula
Model/Catalog Number: 00-5049-011-00
Software Version: N/A
Product Description: Mixing Bowl and Spatula
Component Open, Classified |
JDZ | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 m Open, Classified |
HSB | K241651 |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 m Open, Classified |
HSB | K241651 |
| Nov 3, 2025 | Zimmer, Inc. Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis Open, Classified |
LPH | K190656 |
| Nov 3, 2025 | Zimmer, Inc. Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis Open, Classified |
LPH | K190656 |
| Apr 21, 2025 | Zimmer, Inc. Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented Open, Classified |
LZO | K181171 |
| Apr 21, 2025 | Zimmer, Inc. Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented Open, Classified |
LZO | K181171 |
| Apr 21, 2025 | Zimmer, Inc. Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented Open, Classified |
LZO | K181171 |
| Apr 21, 2025 | Zimmer, Inc. Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented Open, Classified |
LZO | K181171 |
| Apr 21, 2025 | Zimmer, Inc. Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented Open, Classified |
LZO | K181171 |
| Mar 24, 2025 | Zimmer, Inc. NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10 Open, Classified |
JWH | K042271 |
| Mar 24, 2025 | Zimmer, Inc. Z1 Femoral Hip System, Product Number 611777612 Open, Classified |
LZO | K233476 |
| Jan 28, 2025 | Zimmer, Inc. NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10 Open, Classified |
JWH | K960279 |
| Jan 28, 2025 | Zimmer, Inc. NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14 Open, Classified |
JWH | K960279 |
| Nov 1, 2024 | Zimmer, Inc. Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopi Open, Classified |
GEI | K140603 |
| Sep 12, 2024 | Zimmer GmbH Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components.
Item Number: 650-1064 Open, Classified |
LZO | K082996 |
| Sep 12, 2024 | Zimmer GmbH Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components.
Item Number: 650-1066 Open, Classified |
LZO | K082996 |
| Jul 30, 2024 | Zimmer, Inc. CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000
00811400010
00811400100
00811400110
00811400200
00811400210
00811400218
00811400230 Open, Classified |
JDI | K960658 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-018-10 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-018-08 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-018-06 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-018-04 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-017-10 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-017-08 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-017-06 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractu Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 47-2357-018-14 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fracture Open, Classified |
HWC | K070906 |
Newest 50 of 1,073.