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U.S. Department of Health and Human Services

Class 2 Device Recall TRIGEN InterTAN Nail

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  Class 2 Device Recall TRIGEN InterTAN Nail see related information
Date Initiated by Firm April 22, 2022
Create Date May 25, 2022
Recall Status1 Open3, 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/
Smith & Nephew Orthopaedics GmbH
Alemannenstr. 14
Tuttlingen Germany
For Additional Information Contact David Snyder
Manufacturer Reason
for Recall
Right nails were anodized, marked, and labelled as left nails and vice versa
FDA Determined
Cause 2
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.