FDA Device recall Z-2360-2015
Triathlon PS X3 Tibial Insert
- FDA Device
- Class II
- terminated
- Published 2015-08-19
On 2015-08-19 the FDA classified a Class II recall of Triathlon PS X3 Tibial Insert by Stryker Howmedica Osteonics, citing stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialis….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2360-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-29 |
| Published | 2015-08-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
Product
Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component.
Reason
Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.
Identifiers
| code_info | Catalog Number 5532-G-511 Lot LD8D7Y Catalog Number 5537-G-319 Lot TT6JT2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2360-2015%22
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