Class 2 Device Recall Stryker

• Date Initiated by Firm: November 21, 2019
• Create Date: January 07, 2020
• Recall Status: Terminated on November 13, 2020
• Recall Number: Z-0781-2020
• Recall Event ID: 84451
• 510(K)Number: K102885
• Product Classification: Component, traction, invasive - Product Code JEC
• Product: Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric fractures
• Code Information: Lot Number: D30875 UDI : (01)07613327089158(10)D30875
• Recalling Firm/ Manufacturer: Stryker GmbH; Bohnackerweg 1; Selzach Switzerland
• Manufacturer Reason for Recall: Pin To Rod Coupling could not clamp the pin and rod as intended
• FDA Determined Cause: Under Investigation by firm
• Action: Stryker issued Urgent Medical Device Recall - PFA 2227937 letter on November 21, 2019 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 was also issued at the country level. The letter states reason for recall, health risk and action to take: Actions Needed: 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all those 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 are at your facility. A 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.Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-844-782-5565 or email to Strykerortho2917@stericycle.com 5.Hospitals/Branches/Agencies: Return all affected instruments available at your location to the following address. Stryker Orthopaedics/PFA Product Returns PFA 2227937 Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07431
• Distribution: Worldwide distribution - US Nationwide distribution including states of FL, MA, MI, NC, NJ, TX, WA, and countries of Brazil, Italy, South Africa, Netherlands, Spain, and China.
• 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 = JEC