Reported Sep 10, 2014 · Terminated
PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF…
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
8 of 8 products
| # | Product as published |
|---|---|
| 1 | PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top |
| 2 | Left Size 4-11 EF Top |
| 3 | Left Size 7-12 GH Top |
| 4 | Left Size 9-12 J Top |
| 5 | Right Size 3-7 CD Top |
| 6 | Right Size 4-11 EF Top |
| 7 | Right Size 7-12 GH Top |
| 8 | and Right Size 9-12 J Top. |
- Lot codes and dates
- Part Numbers
42517200410425172005104251720061042517200710425272004104252720051042527200610and 42527200710
- Lot numbers
122 of 122 codes
620345706211774262156315621873226224735062314721623724096238183662397160624291906247490662551390625650486259585362614781627004166270229762724349620435486205568162104368621177436214479462165545621772466225628262351288623562446239122862427419624562686250600362551338625643556259776262614786627022926270580862717332620556826206837662068378621447956215272762187323622562836235128962356275623864196244593162456266625585846257575762611087626386726269874962736074627360756233013062563854
- Part Numbers
- Amount recalled
- 77,737 total units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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