FDA Device recall Z-0023-2025
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and rev…
- FDA Device
- Class II
- ongoing
- Published 2024-10-16
On 2024-10-16 the FDA classified a Class II recall of Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and rev… by Howmedica Osteonics, citing 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 tib….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0023-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-04 |
| Published | 2024-10-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Howmedica Osteonics |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI-DI: 07613327026306 Lot numbers: LZX4LB, OLH7VA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0023-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.