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Class IIOngoing

Howmedica Osteonics Corp. recalls 4 products

Recall date · record updated Oct 21, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Howmedica Osteonics Corp.
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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 notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99883…

Products (4)

  1. TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.

    Codes/lots: Catalog Number: 6543-6-506. GTIN: 07613327548082. All lot numbers used prior to the correction date of May 8, 2026 are impacted.Quantity: 605 traysRecall no. Z-0164-2027Class II

  2. TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.

    Codes/lots: Catalog Number: 6543-6-507. GTIN: 07613327557138. All lot numbers used prior to the correction date of May 8, 2026 are impacted.Quantity: 582 traysRecall no. Z-0165-2027Class II

  3. Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.

    Codes/lots: Catalog Number: 6543-6-514. GTIN: 07613327562859. All lot numbers used prior to the correction date of May 8, 2026 are impacted.Quantity: 359 traysRecall no. Z-0166-2027Class II

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

    Codes/lots: Catalog Number: 6543-6-519. GTIN: 07613327555127. All lot numbers used prior to the correction date of May 8, 2026 are impacted.Quantity: 577 traysRecall no. Z-0167-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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