Class 2 Device Recall stryker Precision Thin

• Date Initiated by Firm: January 08, 2025
• Date Posted: February 11, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1139-2025
• Recall Event ID: 96098
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
• Code Information: GTIN 04546540466549, Lot Number 23070017
• Recalling Firm/ Manufacturer: Stryker Corporation; 1941 Stryker Way; Portage MI 49002-9711
• For Additional Information Contact: Brooke Thompson; 269-290-0524
• Manufacturer Reason for Recall: Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
• FDA Determined Cause: Process control
• Action: Stryker issued an URGENT MEDICAL DEVICE recall notice to its consignees on 01/08/2025 via FedEx. The notice explained the issue, potential risk, and requested the affected items be quarantined pending return. Stryker will issue a shipping label to the consignee once the response form has been received. Distributors were directed to forward the notice to all those to whom the affected devices were distributed.
• Quantity in Commerce: 238 units
• Distribution: Worldwide 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.