medical MODERATE Updated 2026-10-21

Howmedica Osteonics Corp. recalls TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6

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Recalled Product

TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.

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Hazard / Issue

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.

Issued by

FDA

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.
Lot/Code Info: Catalog Number: 6543-6-519. GTIN: 07613327555127. All lot numbers used prior to the correction date of May 8, 2026 are impacted.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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