Company ยท US
Zimmer Surgical Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2019. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
28recalls (6 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Zimmer Surgical Inc Brand Name: Sterile Tourniquet Hoses
Product Name: A.T.S 4000 TS Tourniquet Systems Single Hose with CPC Connectors
Model/Catalog Number: 60-4009-101-00
Software Version: N/A
Product Description: Sing Open, Classified |
KCY | None listed |
| Jul 2, 2026 | Zimmer Surgical Inc Brand Name: Sterile Tourniquet Hoses
Product Name: A.T.S 4000 TS Tourniquet Systems Dual Hose with CPC Connectors
Model/Catalog Number: 60-1812-101-00
Software Version: N/A
Product Description: Dual S Open, Classified |
KCY | None listed |
| Jan 28, 2026 | Zimmer Surgical Inc Brand Name: Zimmer Tourniquet Systems
Product Name: A.T.S. 3200TS Tourniquet Systems
Model/Catalog Number: 60320010100
Software Version: Software version v2.06 or prior are within scope of the recall Open, Classified |
KCY | K050411 |
| Jan 28, 2026 | Zimmer Surgical Inc Brand Name: Zimmer Tourniquet Systems
Product Name: A.T.S. 5000TS Tourniquet Systems
Model/Catalog Number: 60500010100
Software Version: Software version v2.04 or prior are within scope of the recall Open, Classified |
KCY | K202919 |
| Dec 15, 2025 | Zimmer Surgical Inc Zimmer Dermatome AN, Model/Catalog Number: 88710100 Open, Classified |
GFD | None listed |
| Dec 15, 2025 | Zimmer Surgical Inc Zimmer Air Dermatome, Model/Catalog Number: 00880100100 Open, Classified |
GFD | None listed |
| Feb 13, 2024 | Zimmer Surgical Inc 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier Open, Classified |
FZW | None listed |
| Oct 6, 2023 | Zimmer Surgical Inc Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capab Open, Classified |
GFD | None listed |
| Jan 28, 2020 | Zimmer Surgical Inc Zimmer Sterile Disposable
Tourniquet Cuff with Protective
Sleeve and PLC, Dual Port, Dual
Bladder, Item No. 60708015200, UDI (01)00889024377547
(17)230812(10)27968701
The product is a tourniquet - Pr Terminated |
KCY | None listed |
| Apr 16, 2019 | Zimmer Surgical Inc Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece:
Alvarado Foot Piece: Item Number: 00-1320-010-00
Alvarado Knee Holder Base Plate Assemb Terminated |
JEB | None listed |
| Jun 8, 2018 | Zimmer Surgical Inc Zimmer Dermatone AN, Model No. 88710100 Terminated |
GFD | None listed |
| Jul 27, 2017 | Zimmer Surgical Inc A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622
Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extrem Terminated |
KCY | None listed |
| Jul 27, 2017 | Zimmer Surgical Inc A.T.S. 4000TS Tourniquet Systems, Personalized Pressure.
Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on tho Terminated |
KCY | K123553 |
| Nov 5, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, wh Terminated |
GFD | None listed |
| Aug 4, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, Terminated |
GFD | None listed |
| Aug 4, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, Terminated |
GFD | None listed |
| Aug 4, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00.
Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plat Terminated |
GFD | None listed |
| Aug 4, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when Terminated |
GFD | None listed |
| Aug 4, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 .
Width plates is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width Terminated |
GFD | None listed |
| Aug 4, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01.
The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual Terminated |
GFD | None listed |
| Aug 4, 2016 | Zimmer Surgical Inc Zimmer Air Dermatome II Handpiece, item number 00-8851-001-00.
The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is pack Terminated |
GFD | None listed |
| Aug 6, 2015 | Zimmer Surgical Inc 30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arter Terminated |
KCY | None listed |
| Aug 6, 2015 | Zimmer Surgical Inc 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood Terminated |
KCY | None listed |
| May 13, 2015 | Zimmer Surgical Inc Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc.
Intended for post-operative collection of wound drainage. Terminated |
GCY | None listed |
| Oct 31, 2014 | Zimmer Surgical Inc UNIVERSAL Modular Electric/Battery Handpiece for surgery
The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece b Terminated |
HAB | None listed |
| Jun 5, 2013 | Zimmer Surgical Inc Zimmer Air Dermatome II, REF 00-8851-001-01
handpiece, w/o hose, Rx, non-sterile
grafting instruments intended to provide variable graft thickness and width capabilities. Terminated |
GFD | None listed |
| Jun 5, 2013 | Zimmer Surgical Inc Zimmer Air Dermatome II, REF 00-8851-001-00
handpiece
Rx, non-sterile
grafting instruments intended to provide variable graft thickness and width capabilities Terminated |
GFD | None listed |
| Jun 5, 2013 | Zimmer Surgical Inc The Zimmer Air Dermatome, REF 00- 8801- 001- 00 ,
Rx, non-sterile
grafting instruments intended to provide variable graft thickness and width capabilities Terminated |
GFD | None listed |