Recall record at a glance
| Official record | Z-2329-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Howmedica Osteonics Corp. |
| Report date | Aug 25, 2021 |
| Recall initiation date | Jul 1, 2021 |
| Quantity | 14 US; 2 OUS |
| Location | Mahwah, NJ, United States |
Official product description
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Why the product was recalled
The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.
Distribution information
Worldwide distribution - US Nationwide distribution in the states AR, CO, MN, MS, NJ, OK, PA, TX and the countries of China and Italy.
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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