Recall record at a glance
| Official record | Z-0299-2020 |
|---|---|
| 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
Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211217 00434211313 00434211413 00434211417 00434211513 00434211613 00434211713 00434211813 00434810613 00434810813 00434810817 00434810913 00434811013 00434811017 00434811113 00434811213 00434811217 00434811313 00434811413 00434811417 00434811513 00434811613 00434811713 00434811813 00434900813 00434900817 00434901013 00434901017 00434901213 00434901217 00434901413 00434903700 00434903811 00434903909 00434903912 32855090339 32855090353 32855090368 32855090375 32855090395 32855090512 32855090519 32855090520 32855090531 32855090585 32855090593 32855090598 32855090599 32855090628 32855090636 32855090637 32855090640 32855090658 32855090659 32855090734 47430703100 47430704100 47430706100
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
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