Recall record at a glance
| Official record | Z-0381-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Biomet, Inc. |
| Report date | Nov 29, 2023 |
| Recall initiation date | Oct 9, 2023 |
| Quantity | N/A |
| Location | Warsaw, IN, United States |
Official product description
Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178558
Why the product was recalled
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Distribution information
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
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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