Class 2 Device Recall Stryker

• Date Initiated by Firm: May 07, 2020
• Date Posted: June 16, 2020
• Recall Status: Terminated on September 21, 2023
• Recall Number: Z-2379-2020
• Recall Event ID: 85681
• 510(K)Number: K032244
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm; Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
• Code Information: Lot Number: K01CF9F
• Recalling Firm/ Manufacturer: Stryker GmbH; Bohnackerweg 1; Selzach Switzerland
• Manufacturer Reason for Recall: Seal integrity of the blister pack may be compromised and sterility cannot be assured
• FDA Determined Cause: Process control
• Action: Stryker issued Urgent Medical Device Recall (UMDR) - PFA 2365134 letter on May 7, 2020 to affected US consignees by third-party recall company, Stericycle Inc. (2670 Executive Drive Indianapolis, IN 46241), via UPS 2nd day air. An OUS customer letter will also be issued at the country level The letter states reason for recall, heath 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 aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list is at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. 4. Under 21 CFR 803, manufactures are also required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by emailing soprodexpreports@stryker.com. 5. A response is required, even though you may not have any physical inventory on site anymore. 6. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-888-912-8457 or email to StrykerOrtho8810@Stericycle.com. 7. Hospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions. 8.Branches/Agencies Only: Return all affected devices available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive, Dock M-East Mahwah, NJ 07430 Ref. PFA 2365134 Questions or concerns after reviewing the letter, please contact Customer Service at (201) 831-5000.
• Quantity in Commerce: US 3; OUS 13
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
• 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 = HSB and Original Applicant = HOWMEDICA OSTEONICS CORP.