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U.S. Department of Health and Human Services

Class 2 Device Recall LAG SCREW 3.2MM GUIDE PIN SLEEVE

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  Class 2 Device Recall LAG SCREW 3.2MM GUIDE PIN SLEEVE see related information
Date Initiated by Firm October 07, 2019
Create Date November 08, 2019
Recall Status1 Terminated 3 on March 08, 2023
Recall Number Z-0351-2020
Recall Event ID 84059
510(K)Number K122170  
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; intracapsular fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening.
Code Information Batch Numbers: 18DM11613A, 18HM02575, 18HM13327A, 18HM20956A
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David Snyder
978-749-1440
Manufacturer Reason
for Recall		 LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully compress.
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by letter and email on 10/07/2019. The letter explained the issue and requested the return of the recalled product.
Quantity in Commerce 116 devices
Distribution Worldwide distributions - US Nationwide distributions and countries of Belgium, Brazil, China, Columbia, France, Great Britain, India, Japan, Russia, Singapore, South Africa, Spain,and United Arab Emirates.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LXH and Original Applicant = SMITH & NEPHEW, INC.
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