Reported Sep 10, 2014 · Terminated
PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the…
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 Posterior Stabilized Tibial Articular Surface Provisional TOP with the following
16 of 16 products
| # | Product as published |
|---|---|
| 1 | L 3-5 CD |
| 2 | L 6-9 CD |
| 3 | L 3-5 EF |
| 4 | L 6-9 EF |
| 5 | L 10-11 EF |
| 6 | L 6-9 GH |
| 7 | L 10-12 GH |
| 8 | L 10-12 J |
| 9 | R 3-5 CD |
| 10 | R 6-9 CD |
| 11 | R 3-5 EF |
| 12 | R 6-9 EF |
| 13 | R 10-11 EF |
| 14 | R 6-9 GH |
| 15 | R 10-12 GH |
| 16 | and R 10-12 J. |
- Lot codes and dates
- Part Numbers
425176004104251760051042517600610425176007104251760081042517600910425176010104251760111042527600410425276005104252760061042527600710425276008104252760091042527601010and 42527601110
- Lot numbers
119 of 119 codes
623425266242391862423919624239206242741462482212625637456261222562656072627406986234252762405895624304016250417962511925625637846263866562695870623430666240696762432146625154866256432462691390627173356235129162374838624153076243039762518138626225276269687562357867623747966242783662441229625119246256390862565948625905236269529562361315623766626242019262434748625181376254005962563778626271316269873362363684623670786242391462430398624946626256593662658602626958766244593062340579
- 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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