Recall record at a glance
| Official record | Z-0307-2020 |
|---|---|
| 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 Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234700404 00234700406 00234700408 00234700410 00234700412 00234700414 00234700416 00234700502 00234700504 00234700506 00234700508 00234700510 00234700512 00234700514 00234700602 00234700604 00234700606 00234700608 00234700610 00234700612 00234700614 00234700704 00234700706 00234700708 00234700710 00234700712 00234700714 00234700716 00234700718 00234700720 00234700804 00234700806 00234700808 00234700810 00234700812 00234700814 00234700816 00234700818 00234700820 00234700904 00234700906 00234700908 00234700910 00234700912 00234700914 00234700916 00234700918 00234700920 00234701004 00234701006 00234701008 00234701010 00234701012 00234701014 00234701016 00234701018 00234701020 00234701104 00234701106 00234701108 00234701110 00234701204 00234701206 00234701208 00234701210 00234701304 00234701306 00234701308 00234701404 00234701406 00234701408 00234703500 00234703600
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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