Class 2 Device Recall KWIRE

• Date Initiated by Firm: July 09, 2024
• Date Posted: September 19, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3171-2024
• Recall Event ID: 95154
• Product Classification: Pin, fixation, smooth - Product Code HTY
• Product: DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
• Code Information: Batch 23GNX0077
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 1450 E Brooks Rd; Memphis TN 38116-1804
• For Additional Information Contact: David Snyder; 978-749-1440
• Manufacturer Reason for Recall: Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
• FDA Determined Cause: Packaging change control
• Action: Smith & Nephew issued and Urgent Medical Device Recall Notice to its consignees on 07/09/2024 via overnight mail. The notice explained the problem, potential risk, and requested the return of the product. Sales representatives, District Offices, and/or Distributors were directed to notify their customers. For questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.
• Quantity in Commerce: 24 units
• Distribution: US, Canada, Norway
• 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.