Recall record at a glance
| Official record | Z-0317-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Zimmer Biomet, Inc. |
| Report date | Nov 13, 2019 |
| Recall initiation date | Oct 10, 2019 |
| Quantity | 5,459,583 total devices |
| Location | Warsaw, IN, United States |
Official product description
Periarticular locking plate elbow-sterile, Item Nos. 47235800503 47235800509 47235800511 47235800515 47235800519 47235800603 47235800605 47235800607 47235800609 47235800611 47235800615 47235800619 47235800705 47235800711 47235800715 47235800803 47235800805 47235800807 47235800811 47235800815 47235800911 47235800913 47235800915 47235801209 47235801211 47235801213 47235801215 47235802305 47235802307 47235802311 47235802315 47235802405 47235802407 47235802409 47235802411 47235802415 47235810707 47235810711 47235810715 47235810805 47235810807 47235810811 47235810815
Why the product was recalled
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Distribution information
Distributed nationwide.
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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