—#190726

Product

Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalog# 6541-9-109

FDA product code: FSM — Tray, Surgical, Instrument
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lots #: 0552101A596, 0552101A602 GTIN#: 07613327461503

Why it was recalled

Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Stryker issued an Urgent Medical Device Recall (UMDR) PFA 2799625 issued on Wednesday, November 24, 2021 to all affected U.S. consignees and Stryker Branches by a third-party recall company via UPS 2-day air. Letter states reason for recall, health risk and action to take: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Discontinue use of the recalled Triathlon Pro Tibial Preparation Tray, Rev. AC, P/N # 6541-9-109, and return the tray and its content to Stryker. 4. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-844-782-5561 or email to strykerortho2979@sedgwick.com. 5. Hospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions. 6. Branches/Agencies Only: Please forward this Urgent Medical Device Recall to the individuals or organizations who have consigned product, if applicable. Return all affected devices available at your location to the following address. Stryker Orthopaedics/PFA Product Returns (Ref. PFA 2799625) Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Please assist us in meeting our regulatory obligation by returning the attached Urgent Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. If you have any questions or concerns after reviewing this letter, please contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: US Nationwide distribution in the states of GA, MI, NC, TX.

Timeline

Recall initiated: 2021-11-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190726. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.