FDA Device recall Z-2329-2021
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
- FDA Device
- Class II
- terminated
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 by Howmedica Osteonics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2329-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-01 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Howmedica Osteonics |
| Distribution | US |
Product
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Reason
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.
Identifiers
| code_info | Lot JHS2H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2329-2021%22
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