Reported Jul 8, 2015 · Terminated
Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis…
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?
- Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
- Lot codes and dates
- item 6215-12-185 Lots
63 of 63 codes
7884165788473678847377884738789033011011448110126606039416960415420605157936056453060601129606140146079704460803056608418486092265560922656609278536098911261017152611041926113587261200531612845716136691961464308615053106153302561566733617421516178036161784264618341926183477861840307619303766194788461947885620979106214692562195165622494316228127062305675623179876235864362448678625369016253690262536903625465276256037262587577626109896262471562624716626247176262471862709664
- item 6215-12-185 Lots
- Amount recalled
- 352
Where it was sold
Why it was recalled
Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection.
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.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.