Triathlon Universal TS Baseplate Size 2 — Class II medical device recall Z-0023-2025
Ongoing recall by Howmedica Osteonics Corp., reported 2024-10-16, distributed nationwide. Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engageme
| Recall number | Z-0023-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2024-09-04 |
| Classified | 2024-10-07 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 16 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 07613327026306 |
| Lot numbers | LZX4LB, OLH7VA |
| Model numbers | 5521-B-200 |
Product
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200
Reason for recall
Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
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-0023-2025. 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.