Recall record at a glance
| Official record | Z-1008-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Zimmer Biomet, Inc. |
| Report date | Mar 21, 2018 |
| Recall initiation date | Sep 15, 2017 |
| Quantity | 23 |
| Location | Warsaw, IN, United States |
Official product description
36MM COCR MODULAR HD -6MM
Why the product was recalled
One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.
Distribution information
Outside USA
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: E-Mail.
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.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.