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U.S. Department of Health and Human Services

Class 2 Device Recall TRIGEN

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 Class 2 Device Recall TRIGENsee related information
Date Initiated by FirmMarch 18, 2025
Date PostedMay 19, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1806-2025
Recall Event ID 96586
510(K)NumberK092748 K210980 
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
ProductMETA-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Code Information UDI-DI: 00885556132975. Lot: 24CT81426. Expiration: 25-Mar-2034
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact
901-396-2121
Manufacturer Reason
for Recall		Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
FDA Determined
Cause 2		Process control
ActionOn 3/18/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) Inspect your inventory and locate any affected devices and quarantine them. 2) If you are a sales rep, district office, or distributor, you must notify your customers of the field action and ensure that the required actions are complete. 3) Complete and return the notice response section via email to FieldActions@smith-nephew.com If you have any questions email the firm at the email address above.
Quantity in Commerce75
DistributionWorldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH, NY, AL, IA, MA, NV, MO, WA, LA, TN, NC, KY, NM, NJ, AZ and the country of ZA.
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 = HSB
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