Class 2 Device Recall Farabeuf Clamp for 3.5mm Screws PRO

• Date Initiated by Firm: May 04, 2018
• Create Date: June 15, 2018
• Recall Status: Terminated on April 27, 2020
• Recall Number: Z-2244-2018
• Recall Event ID: 80198
• Product Classification: Clamp - Product Code HXD
• Product: Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
• Code Information: Lot # 04857V
• Recalling Firm/ Manufacturer: Stryker GmbH; Bohnackerweg 1; Selzach Switzerland
• For Additional Information Contact: Aminah Crawford; 201-831-5272
• Manufacturer Reason for Recall: Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm
• FDA Determined Cause: Other
• Action: On May 8, 2018, URGENT PRODUCT RECALL and BUSINESS REPLY notices were issued to U.S.A customers via UPS. Customers are encouraged to take 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 by submitted the completed response form via email to: StrykerOrtho6487@stericycle.com, 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. Customers with questions may call 201-831-5000.
• Quantity in Commerce: 18 parts (10 parts quarantined)
• Distribution: AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX
• 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.