Reported Jul 9, 2014 · Terminated
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part…
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?
- NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
- Lot codes and dates
- Size 3
- includes the following Lot numbers
231 of 231 codes
3703163721403961414610614146116144229461442295614422966144229761450963614509646145096561454951614549526145495361459941614599426147512361475124614880646148806561488066614880676148806861497512614975136150722361507224615181516151815361518154615263986152639961558358615583596155836061558361615673366156733761567338615673396159208461592085615920866159208761627191616271926162719361627194616271956162719661627197616271986162719961627201616272026164392861643929616439306164393161643932
- Amount recalled
- 41,180 total
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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