Reported Jul 9, 2014 · Terminated
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. 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 2. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
- Lot codes and dates
- Size 2
- includes the following Lot numbers
91 of 91 codes
372146506141741561417416614422786145993861459939614599406148806961497510614975116151814861518149615380236154397261543973615439746156733561592049615920506162718961627190616725546167255561672556616725576167255861682128616821296172166561721666617216676177411861774119617741206182710961827110618271116186308061863081618630836186308461863085619124346191537061915371619790216197902261979023620161756202027662041296620606106206953362091728621412556214125662141257621553056215530662155307
- 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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