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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 04, 2014
Date PostedMay 20, 2014
Recall Status1 Terminated 3 on July 01, 2017
Recall NumberZ-1637-2014
Recall Event ID 68043
510(K)NumberK040212 
Product Classification Nail, fixation, bone - Product Code JDS
ProductTRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device.
Code Information (1) REF 71676515, Lot Number 13LT36602  (2) REF 71676556, Lot Numbers: 13LT36604, 13MT37354, 13MT37947, 14AT38705, 14AT38714  (3) REF 71676558, Lot Numbers: 13KT36282, 13MT37356, 13MT37664, 13MT37949, 14AT38187  (4) REF 71676561, Lot Numbers: 13LT36605, 13MT37358, 14AT38188
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information ContactJoe Metzger
978-749-1330
Manufacturer Reason
for Recall		A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
FDA Determined
Cause 2		Process control
ActionThe firm initiated the recall via an "Urgent - Product Recall 1st Notification - Urgent" letter and e-mail on 04/04/2014, identifying the product, explaining the problem, and the potential risk associated with using the product. Customers are to inspect their inventory, and locate and quarantine any affected product. Additionally, the Inventory Return Certification form should be completed and returned along with any affected product identified, once a Return Authorization number has been obtained from Smith & Nephew's Safety Affairs Department.
Quantity in Commerce1,253 units total
DistributionWorldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JDS
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