Recall record at a glance
| Official record | Z-1018-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Biomet, Inc. |
| Report date | Feb 1, 2023 |
| Recall initiation date | Dec 15, 2022 |
| Quantity | 7 units |
| Location | Warsaw, IN, United States |
Official product description
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341
Why the product was recalled
Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
Distribution information
Worldwide distribution - US Nationwide distribution in the states of IN, KY and the countries of Canada, New Zealand, Japan, Netherlands.
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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