Class 2 Device Recall Femoral Nail

• Date Initiated by Firm: April 27, 2018
• Create Date: July 10, 2018
• Recall Status: Terminated on May 21, 2020
• Recall Number: Z-2402-2018
• Recall Event ID: 80131
• 510(K)Number: K003018
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S
• Code Information: GTIN: 04546540646583; Lot code: K08D58D
• Recalling Firm/ Manufacturer: Stryker GmbH; Bohnackerweg 1; Selzach Switzerland
• For Additional Information Contact: Aminah Crawford; 201-831-5272
• Manufacturer Reason for Recall: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
• FDA Determined Cause: Employee error
• Action: Urgent Product Recall letters dated 4/27/18 were distributed to customers. The letters instructed customers to perform the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 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. Response is required, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. 6. Branches/Agencies: Return all affected products available at your location to: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 PR 1774317 Event 6020 7. Hospitals/Branches/Agencies: Complete and sign the enclosed Business Reply Form and fax to 1-888-230-2125 or to Email: strykerortho6020@stericycle.com
• Distribution: The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
• 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.