510(k) K123459 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 22, 2013 |
| Received | Nov 9, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123459
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2015 | Zimmer, Inc. Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04.
Product Usage: The Persona TASPs are sterilizable instruments Inten Terminated |
OIY | None listed |
| Sep 4, 2014 | Zimmer, 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 |
JWH | None listed |
| Sep 4, 2014 | Zimmer, 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 |
JWH | None listed |
| Sep 4, 2014 | Zimmer, 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 |
JWH | None listed |
| Sep 4, 2014 | Zimmer, 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 |
JWH | None listed |
| Sep 4, 2014 | Zimmer, 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 |
JWH | None listed |
| Sep 4, 2014 | Zimmer, 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 |
JWH | None listed |
| Aug 21, 2014 | Zimmer, Inc. Persona (TM) The Personalized Knee System
CR Tibial Articular Surface Provisional Top
Nonsterile
TASP CR L 3-9 CD TOP Terminated |
JWH | None listed |
| Aug 21, 2014 | Zimmer, Inc. Persona (TM) The Personalized Knee System
Tibial Articular Surface Provisional Bottom
Nonsterile
PSN A/S PROV L CD BOTTOM +0MM
PSN A/S PROV L CD BOTTOM +6MM
PSN A/S PROV L EF BOTTOM +0MM
PSN A/S PROV Terminated |
JWH | None listed |
| Aug 21, 2014 | Zimmer, Inc. Persona (TM) The Personalized Knee System
CPS Tibial Articular Surface Provisional Top
Nonsterile
TASP MLC L 3-5 CD TOP
TASP MLC L 6-9 CD TOP
TASP MLC L 3-5 EF TOP
TASP MLC L 6-9 EF TOP
TASP MLC L 10 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.