Howmedica Osteonics Corp.: Tray, Surgical, Instrument
Recall Summary Howmedica Osteonics Corp. is recalling TS Femoral Prep Trays (Catalog Number 6543-6-507) used in orthopedic surgery because the sterilization instructions may result in moisture remaining on the trays after sterilization. The trays were distributed to hospitals and surgical facilities in the U.S. and internationally, with 158 units sent outside the U.S.
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-16
- Status
- Open, Classified
- Distribution
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/aef9c3a5-94ff-4e0f-906c-f30166201499