FDA Device recall Z-1265-2024
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM by Howmedica Osteonics, citing potential packaging breaches of inner blister and outer sterile blister.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1265-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-06 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Howmedica Osteonics |
| Distribution | US |
Product
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Reason
Potential packaging breaches of inner blister and outer sterile blister.
Identifiers
| code_info | Part No. 5537-G-416-E; GTIN: 07613327287745; Lot No. H21A0K, XY776E; Expiration Date: 10/07/2028. |
|---|
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-1265-2024%22
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