- Recalling firm
- Howmedica Osteonics Corp.
- 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.
- Affected products (lot / model / serial)
- Catalog Number: 6543-6-519. GTIN: 07613327555127. All lot numbers used prior to the correction date of May 8, 2026 are impacted.
- Units affected
- 577 trays
- 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.
- Firm location
- Mahwah, NJ, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0167-2027
- Recall initiated
- September 16, 2026
- FDA classification date
- October 15, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99883
- Last updated on HTM Vibe
- October 27, 2026
