Recall record at a glance
| Official record | Z-2514-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Aesculap Implant Systems LLC |
| Report date | Sep 29, 2021 |
| Recall initiation date | Mar 19, 2021 |
| Location | Center Valley, PA, United States |
Official product description
Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NO157Z AS UNIVATION XF TIBIA CEMENTED T2 RM; NO158Z AS UNIVATION XF TIBIA CEMENTED T3 RM; NO159Z AS UNIVATION XF TIBIA CEMENTED T4 RM; NO160Z AS UNIVATION XF TIBIA CEMENTED T5 RM; NO161Z AS UNIVATION XF TIBIA CEMENTED T6 RM; NO162Z AS UNIVATION XF TIBIA CEMENTED T1 LM; NO163Z AS UNIVATION XF TIBIA CEMENTED T2 LM; NO164Z AS UNIVATION XF TIBIA CEMENTED T3 LM; NO165Z AS UNIVATION XF TIBIA CEMENTED T4 LM; NO166Z AS UNIVATION XF TIBIA CEMENTED T5 LM; NO167Z AS UNIVATION XF TIBIA CEMENTED T6 LM;
Why the product was recalled
Malfunction- loosening of the implant resulting in a potential revision surgery
Distribution information
US Nationwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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