ClearanceBrief
510(k) K113369 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

ZIMMER PERSONA KNEE SYSTEM

ApplicantZimmer, Inc., Warsaw IN, US
DecisionSubstantially Equivalent, Mar 27, 2012
ReceivedNov 15, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K113369

DateFirm and productCodeLinked 510(k)
Aug 7, 2017Zimmer Biomet, Inc.
Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.
Terminated
JWHNone listed
Aug 7, 2017Zimmer Biomet, Inc.
Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
Terminated
JWHNone listed
Aug 7, 2017Zimmer Biomet, Inc.
Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
Terminated
JWHNone listed
Aug 7, 2017Zimmer Biomet, Inc.
Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.
Terminated
JWHNone listed
Apr 6, 2016Zimmer Manufacturing B.V.
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14
Terminated
JWHNone listed
Apr 6, 2016Zimmer Manufacturing B.V.
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18
Terminated
JWHNone listed
Mar 12, 2016Zimmer Manufacturing B.V.
Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN ALL POLY PAT PLY 29MM 42540000032 PSN ALL POLY PAT PLY 32MM 4
Terminated
JWHNone listed
Apr 1, 2015Zimmer, Inc.
Brand Name: Persona Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Th
Terminated
JWHNone listed
Feb 3, 2015Zimmer, Inc.
Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
Terminated
JWHNone listed
Dec 23, 2014Zimmer, Inc.
Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Perso
Terminated
JWHNone listed
Nov 8, 2014Zimmer, Inc.
Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis,
Terminated
JWHNone listed
Oct 23, 2014Zimmer, Inc.
The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Artic
Terminated
JWHNone listed
Sep 4, 2014Zimmer, Inc.
PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM;
Terminated
JWHNone listed
Sep 4, 2014Zimmer, Inc.
PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12
Terminated
JWHNone listed
Sep 4, 2014Zimmer, Inc.
PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Left Size 3-9
Terminated
JWHNone listed
Sep 4, 2014Zimmer, Inc.
PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom;
Terminated
JWHNone listed
Sep 4, 2014Zimmer, Inc.
PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-1
Terminated
JWHNone listed
Sep 4, 2014Zimmer, Inc.
PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3-7 CD Top; Right Siz
Terminated
JWHNone listed
Aug 21, 2014Zimmer, Inc.
Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD
Terminated
JWHNone listed
Aug 21, 2014Zimmer, Inc.
Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +6MM TASP L EF BOTTOM, +0MM TASP L EF BOTTOM, +6MM TASP L GH
Terminated
JWHNone listed
Aug 21, 2014Zimmer, Inc.
Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L 3-7 CD TOP TASP UC L 4-11 EF TOP TASP UC L 7-12 GH TOP TASP UC L 9-12 J TOP
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT This device is indicated for patients with severe knee pain and disabi
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid art
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE E, LEFT TIBIA SIZE E RIGHT This device is indicated for patients with severe knee pain an
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGHT This device is indicated for patients with severe knee pain an
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE G, LEFT TIBIA SIZE G RIGHT This device is indicated for patients with severe knee pain an
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE H, LEFT TIBIA SIZE H RIGHT This device is indicated for patients with severe knee pain an
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis,
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile This drill guide is used with the Persona Knee System for patients with severe knee pai
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: R
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rh
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rh
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C Right This device is used with the Persona Knee System for patients with severe knee pain and d
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left; Size D Right This device is used with the Persona Knee System for patients with severe knee pain and d
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E Left; Size E Right This device is used with the Persona Knee System for patients with severe knee pain and d
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left; Size F Right This device is used with the Persona Knee System for patients with severe knee pain and d
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size G Left; Size G Right This device is used with the Persona Knee System for patients with severe knee pain and d
Terminated
JWHNone listed
Dec 18, 2012Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left; Size H Right This device is used with the Persona Knee System for patients with severe knee pain and d
Terminated
JWHNone listed
Sep 28, 2012Zimmer, Inc.
Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engrave
Terminated
JWHNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.