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
10 of 10 products
| # | Product as published |
|---|---|
| 1 | Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM |
| 2 | NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM |
| 3 | NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM |
| 4 | NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM |
| 5 | NO184Z AS UNIVATION XF FEMUR CEMENTED F5 RM |
| 6 | NO185Z AS UNIVATION XF FEMUR CEMENTED F1 LM |
| 7 | NO186Z AS UNIVATION XF FEMUR CEMENTED F2 LM |
| 8 | NO187Z AS UNIVATION XF FEMUR CEMENTED F3 LM |
| 9 | NO188Z AS UNIVATION XF FEMUR CEMENTED F4 LM |
| 10 | NO189Z AS UNIVATION XF FEMUR CEMENTED F5 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.
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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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