Reported Sep 29, 2021 · Terminated
Univation X System knee implant devices as follows
Aesculap Implant Systems LLC
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: Aesculap Implant Systems LLC · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217
Is this the product you have?
Univation X System knee implant devices as follows
12 of 12 products
| # | Product as published |
|---|---|
| 1 | Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM |
| 2 | NO157Z AS UNIVATION XF TIBIA CEMENTED T2 RM |
| 3 | NO158Z AS UNIVATION XF TIBIA CEMENTED T3 RM |
| 4 | NO159Z AS UNIVATION XF TIBIA CEMENTED T4 RM |
| 5 | NO160Z AS UNIVATION XF TIBIA CEMENTED T5 RM |
| 6 | NO161Z AS UNIVATION XF TIBIA CEMENTED T6 RM |
| 7 | NO162Z AS UNIVATION XF TIBIA CEMENTED T1 LM |
| 8 | NO163Z AS UNIVATION XF TIBIA CEMENTED T2 LM |
| 9 | NO164Z AS UNIVATION XF TIBIA CEMENTED T3 LM |
| 10 | NO165Z AS UNIVATION XF TIBIA CEMENTED T4 LM |
| 11 | NO166Z AS UNIVATION XF TIBIA CEMENTED T5 LM |
| 12 | NO167Z AS UNIVATION XF TIBIA CEMENTED T6 LM |
- Lot codes and dates
- All lots
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Malfunction- loosening of the implant resulting in a potential revision surgery
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 Aesculap Implant Systems LLC 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.