Class 2 Device Recall Nail Insertion Sleeve

• Date Initiated by Firm: May 27, 2021
• Create Date: July 30, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2170-2021
• Recall Event ID: 88240
• 510(K)Number: K131365
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
• Code Information: GTIN 07613327005417, Lot Number K03CC50
• Recalling Firm/ Manufacturer: Stryker GmbH; Bohnackerweg 1; Selzach Switzerland
• For Additional Information Contact: Loriann Russo; 201-831-5272
• Manufacturer Reason for Recall: The devices have a different inner diameter than the diameter specified on the outer box label.
• FDA Determined Cause: Process control
• Action: An URGENT MEDICAL DEVICE RECALL notice dated 5/27/21 was sent to customers. Actions to be Taken by the Customer/User: Our records indicate that you may have received one or more of the affected products. It is Strykers 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 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 1-888-879-4609 or email to StrykerOrtho8434@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 2644769 Please assist us in meeting our regulatory obligation by faxing back the attached Urgent Medical Device Recall Business
• Quantity in Commerce: 52
• Distribution: US Nationwide Distribution
• 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 = HSB and Original Applicant = Stryker Trauma AG