Reported Sep 10, 2014 · Terminated
PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left 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 Tibial Articular Surface Provisional Left with the following
16 of 16 products
| # | Product as published |
|---|---|
| 1 | Size CD +0 mm Thickness Bottom(TB) |
| 2 | Size CD +6 mm Thickness Bottom |
| 3 | Size EF +0 mm Thickness Bottom |
| 4 | Size EF +6 mm TB |
| 5 | Size GH +0 mm TB |
| 6 | Size GH +6 mm TB |
| 7 | Size J +0 mm TB |
| 8 | Size J +6 mm TB |
| 9 | Right Size 1-2 CD +0 mm TB |
| 10 | Right Size CD +6 mm TB |
| 11 | Right Size EF +0 mm TB |
| 12 | Right Size EF +6 mm TB |
| 13 | Right Size GH +0 mm TB |
| 14 | Right Size GH +6 mm TB |
| 15 | Right Size J +0 mm TB |
| 16 | and Right Size J +6 mm TB. |
- Lot codes and dates
- Part Numbers
425170003034251700031342517000505425170005154251700070742517000717425170009094251700091942527000303425270003134252700050542527000515425270007074252700071742527000909and 42527000919
- Lot numbers
389 of 389 codes
620223406202497362062232621043676218731462187315621903676219037062265725623018626231467562355857623851266238513262403987624140176242024462456269625060266250604462531664625581066256432562596552626002086261479062683419626913856269873062716777627519026275280962765288627740426202497462032099620752716214479162171682621716846218422362187317622392376224815362256256623867576239110862391109624140016241400262456271624749026254438462565106625651076260156462612269626272706267888862684675
- 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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