Reported Sep 10, 2014 · Terminated
PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD…
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 Constrained Tibial Articular Surface Provisional BOTTOM with the following
17 of 17 products
| # | Product as published |
|---|---|
| 1 | L CD +0MM |
| 2 | L CD +6MM |
| 3 | L EF +0MM |
| 4 | L EF +6MM |
| 5 | L GH +0MM |
| 6 | L GH +6MM |
| 7 | L J +0MM |
| 8 | L J +6MM |
| 9 | R CD +0MM |
| 10 | R CD +6MM |
| 11 | R EF +0MM |
| 12 | R EF +6MM |
| 13 | R GH +0MM |
| 14 | R GH +6MM |
| 15 | R J +0MM |
| 16 | R J +6MM |
| 17 | and |
- Lot codes and dates
- Part Numbers
425176003034251760031342517600505425176005154251760070742517600717425176009094251760091942527600303425276003134252760050542527600515425276007074252760071742527600909and 42527600919
- Lot numbers
103 of 103 codes
623453706240272162423922624247966249466562563912625905246269687862717331623472336239961262428432625055756256391762592279626926876235233062416376624321576249079062563913625905256269688162357329623748036241299962432797624907926256391162654931627173346235732862372411624077726243279462463961625254896256391462575756627027586272474362358632623737396240589662432154624639626256391662656074627106266243279062462267625725746244345562456923625682896235786562410790624239216242480462500930
- Part Numbers
- Amount recalled
- 77,737 units total
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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