Data Foundry

Medical device recalls 2021

Triathlon Prim CEM FXD BPLT 7 — Class II medical device recall Z-2329-2021

Terminated recall by Howmedica Osteonics Corp., reported 2021-08-25, distributed nationwide. The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (

Recall numberZ-2329-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmHowmedica Osteonics Corp., Mahwah, NJ, United States
Recall initiated2021-07-01
Classified2021-08-19
Reported by FDA2021-08-25
Terminated2023-05-17
DistributedNationwide (US)
Countries outside the USCN, IT
Lot numbersJHS2H
Model numbers5520B700

Product

Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2329-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.