Z-0166-2027 Class II Ongoing
FDA device recall Z-0166-2027 was initiated by Howmedica Osteonics Corp. on Sep 16, 2026 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 359 trays.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 21, 2026
- Initiation Date
- Sep 16, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 359 trays
Product Description
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Reason for Recall
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.
Distribution Pattern
These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.
Code Information
Catalog Number: 6543-6-514. GTIN: 07613327562859. All lot numbers used prior to the correction date of May 8, 2026 are impacted.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0166-2027
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026