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U.S. Department of Health and Human Services

Class 2 Device Recall TRIGEN (TM) LP SCREW, 4.5 MM X 37.5 MM

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 Class 2 Device Recall TRIGEN (TM) LP SCREW, 4.5 MM X 37.5 MMsee related information
Date Initiated by FirmMarch 06, 2013
Date PostedApril 17, 2013
Recall Status1 Terminated 3 on August 16, 2019
Recall NumberZ-1132-2013
Recall Event ID 64669
510(K)NumberK111025 
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
ProductTRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery
Code Information Lot Number 12FM12182
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		One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).
FDA Determined
Cause 2		Process control
ActionSmith & Nephew sent an Urgent Product Recall Notification letter dated March 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the affected product and quarantine for return. Non-responding consignees were notified again on March 15, 2013, by email. Surgeons were to be notified by letter beginning on March 20, 2013. For questions regarding this recall call 978-749-1330.
Quantity in Commerce23 units
DistributionNationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.
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 = HSB
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