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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Howmedica

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  Class 2 Device Recall Stryker Howmedica see related information
Date Initiated by Firm November 24, 2021
Create Date January 06, 2022
Recall Status1 Open3, Classified
Recall Number Z-0459-2022
Recall Event ID 89190
Product Classification Tray, surgical, instrument - Product Code FSM
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
Code Information Lots #: 0552101A596, 0552101A602 GTIN#: 07613327461503
Recalling Firm/
Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Elizabeth Beato
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
Under Investigation by firm
Action 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
Quantity in Commerce 7 units
Distribution US Nationwide distribution in the states of GA, MI, NC, TX.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.