Class 2 Device Recall Howmedica Osteonics

• Date Initiated by Firm: April 13, 2023
• Date Posted: May 30, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1653-2023
• Recall Event ID: 92257
• 510(K)Number: K173849
• Product Classification: Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
• Product: TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
• Code Information: GTIN: 07613327390698 Lot Number: JH3AHJ
• Recalling Firm/ Manufacturer: Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2006
• For Additional Information Contact: Bradley Curtis Stryker, Joint Replacement Division; 201-831-5000
• Manufacturer Reason for Recall: Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa
• FDA Determined Cause: Under Investigation by firm
• Action: Stryker issued Urgent Medical Device Recall letter n 4/13/23 via UPS 2-Day Air Product Field Action #: 3268231. Letter states reason for recall and action to take: Our records indicate that you may have received the affected product(s). It is Stryker's responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important 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 or organizations who have consigned product. 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. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to strykerortho6707@sedgwick.com / Fax: (877) 546-0444. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices back to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3268231 Please assist us in meeting our regulatory obligation by emailing back 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. 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: 24 units in total
• Distribution: US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan
• 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.

• 510(K) Database: 510(K)s with Product Code = MBH