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U.S. Department of Health and Human Services

Class 2 Device Recall UOC Femoral driver

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  Class 2 Device Recall UOC Femoral driver see related information
Date Initiated by Firm February 10, 2017
Date Posted March 01, 2017
Recall Status1 Terminated 3 on June 28, 2017
Recall Number Z-1692-2017
Recall Event ID 76540
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
Code Information Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units)
Recalling Firm/
Manufacturer		 United Orthopedic Corporation
No. 57 Park Avenue 2, Science Park
Hsinchu Taiwan
For Additional Information Contact Gimpel Chien
8863-5773351 Ext. 2217
Manufacturer Reason
for Recall		 The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.
FDA Determined
Cause 2		 Device Design
Action United Orthopedic Corporation sent an Urgent Field Safety Notice dated January 19, 2017, to all affected consignees via e-mail on February 10. 2017. The Urgent Field Safety Notice instructed consignees to recover any affected units and return them to the manufacturer. A redesigned device will be sent for replacements. Consignees with questions were instructed to call 949-328-3366.
Quantity in Commerce 33 units
Distribution Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.
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.
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