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U.S. Department of Health and Human Services

Class 2 Device Recall Gentle Threads

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  Class 2 Device Recall Gentle Threads see related information
Date Initiated by Firm June 03, 2015
Date Posted July 01, 2015
Recall Status1 Terminated 3 on December 22, 2015
Recall Number Z-1945-2015
Recall Event ID 71526
510(K)Number K982497  
Product Classification Screw, fixation, bone - Product Code HWC
Product Gentle Threads Interference Screw 9x35mm Full Thread.

An interference fixation screw for use in soft tissue reattachment procedures
Code Information Part Number: 905627 Lot: 753410
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Audrey Daenzer
574-372-1570
Manufacturer Reason
for Recall		 Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action On 6/3/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for locating and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in Commerce 41 units
Distribution Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.
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 = HWC and Original Applicant = BIOMET, INC.
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