FDA Device recall Z-0164-2027
TS Universal Baseplate Finishing Tray, Triathlon
- FDA Device
- Class II
- ongoing
- Published 2026-10-21
On 2026-10-21 the FDA classified a Class II recall of TS Universal Baseplate Finishing Tray, Triathlon by Howmedica Osteonics, citing reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0164-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-16 |
| Published | 2026-10-21 |
| Last updated | 2026-10-27 05:30 UTC |
| Company | Howmedica Osteonics |
| Distribution | n/a |
Product
TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
Reason
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
Identifiers
| code_info | Catalog Number: 6543-6-506. GTIN: 07613327548082. All lot numbers used prior to the correction date of May 8, 2026 are impacted. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.
Other recalls by Howmedica Osteonics
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FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured fro…
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All Howmedica Osteonics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0164-2027%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.