Reported Sep 10, 2014 · Terminated
PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following
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?
PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following
8 of 8 products
| # | Product as published |
|---|---|
| 1 | Left Size 3-9 CD Top |
| 2 | Left Size 3-11 EF Top |
| 3 | Left Size 7-12 GH Top |
| 4 | Left Size 9-12 J Top |
| 5 | Left Size 3-9 CD Top |
| 6 | Left Size 3-11 EF Top |
| 7 | Right Size 7-12 GH Top |
| 8 | and Right Size 9-12 J Top. |
- Lot codes and dates
- Part Numbers
42517000410425170005104251700061042517000710425270004104252700051042527000610and 42527000710
- Lot numbers
127 of 127 codes
620249756204354662144792621527256216553862187318623379616237240762386776623971596240591762456263624991706255138662565051625682726257257262663168626913846270749462717346620209206214479362156313621655396218422862353932623561766238510062420242624682776253841262564340626110886261226362690056627022956271733762736078620249766205477662147232621772436218731962187320623590576236495562391222624140066246123362558583625643456260888962638657626462866270274962724348623942796244339762487490
- 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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