Class 2 Device Recall Triathlon Prim CEM FXD BPLT 7

• Date Initiated by Firm: July 01, 2021
• Create Date: August 19, 2021
• Recall Status: Terminated on May 17, 2023
• Recall Number: Z-2329-2021
• Recall Event ID: 88422
• 510(K)Number: K141056
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
• Code Information: Lot JHS2H
• Recalling Firm/ Manufacturer: Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2006
• For Additional Information Contact: Mr. Rehad Gaffoor; 201-831-5000
• Manufacturer Reason for Recall: The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.
• FDA Determined Cause: Under Investigation by firm
• Action: On July 1, 2021, the firm notified customers via Urgent Medical Device Recall. The letter listed the hazards and harms potentially associated with the recalled product and also listed mitigation factors. Patients treated with an affected product should continue to be followed per the normal protocol established by his or her surgeon(s). There are no recommended changes to the frequency of the standard follow-up care protocol. It should be noted that the failure of the insert to fully seat, may not be evident on x-ray unless the insert has dislodged. Actions Needed: Our records indicate that you may have received the affected product(s). It is Strykers responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important follow up communication. We therefore request that you read this notice carefully and complete the following actions. 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. Quarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. Customers should complete and sign the included customer response form and return it to the recalling firm. Hospitals should contact their local sales office or Stryker sales representative directly for product returns and inventory questions. Customers who have further distributed the product should forward should notify downstream accounts and return all affected devices to the recalling firm. For questions pertaining to the recall, please contact Customer Service at (201) 831-5000, or email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
• Quantity in Commerce: 14 US; 2 OUS
• Distribution: Worldwide distribution - US Nationwide distribution in the states AR, CO, MN, MS, NJ, OK, PA, TX and the countries of China and Italy.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JWH and Original Applicant = STRYKER ORTHOPAEDICS