Class 2 Device Recall TRIGEN InterTAN Nail

• Date Initiated by Firm: April 22, 2022
• Create Date: May 25, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1133-2022
• Recall Event ID: 90118
• 510(K)Number: K040212
• Product Classification: Nail, fixation, bone - Product Code JDS
• Product: INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left ; INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
• Code Information: Product number: 71676627 (DI: 00885556131633), Batch Number: 21LT56988; 71676628 (DI: 00885556040027), Batch number: 21LT56989
• Recalling Firm/ Manufacturer: Smith & Nephew Orthopaedics GmbH; Alemannenstr. 14; Tuttlingen Germany
• For Additional Information Contact: David Snyder; 978-749-1440
• Manufacturer Reason for Recall: Right nails were anodized, marked, and labelled as left nails and vice versa
• FDA Determined Cause: Under Investigation by firm
• Action: The firm sent out a recall notification letter via email and overnight mail on 04/22/2022. The letter instructs the consignee to check inventory, return affected product, and complete the response form. Distributors were informed to notify their customers of the field action.
• Quantity in Commerce: 17 units
• Distribution: Distributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and internationally to Canada, Australia.
• 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 = JDS and Original Applicant = SMITH & NEPHEW, INC.