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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 Nailsee related information
Date Initiated by FirmApril 22, 2022
Create DateMay 25, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1133-2022
Recall Event ID 90118
510(K)NumberK040212 
Product Classification Nail, fixation, bone - Product Code JDS
ProductINTERTAN 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
FEI Number 3002465897
Recalling Firm/
Manufacturer		 Smith & Nephew Orthopaedics GmbH
Alemannenstr. 14
Tuttlingen Germany
For Additional Information ContactDavid Snyder
978-749-1440
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
ActionThe 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 Commerce17 units
DistributionDistributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and internationally to Canada, Australia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JDS
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