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U.S. Department of Health and Human Services

Class 2 Device Recall TI ANCHOR 1.9MM W / 20 SUTURE, GFORCE SUTURE ANCHOR,

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  Class 2 Device Recall TI ANCHOR 1.9MM W / 20 SUTURE, GFORCE SUTURE ANCHOR, see related information
Date Initiated by Firm January 11, 2011
Date Posted March 04, 2011
Recall Status1 Terminated 3 on July 11, 2011
Recall Number Z-1524-2011
Recall Event ID 57854
510(K)Number K100579  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product TI ANCHOR 1.9MM W / 2-0 SUTURE, G-FORCE ¿ SUTURE ANCHOR, Tissue Anchor, REF 86TA-1920, Rx ONLY, Sterile EO, Wright, Arlington, TN USA
Used in the repair of tendons and ligaments
Code Information Lot Numbers: 060WM037106, 060WM37118, 060WM37119, 070WM037147
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information Contact Cathy A.M. Park
901-867-4324
Manufacturer Reason
for Recall		 Driver may break during use.
FDA Determined
Cause 2		 Other
Action Wright Medical Technology Inc initiated their recall of the product by telephone to their distributors on January 11, 2011. The firm followed with letters sent on February 1, 2011, to distributors, hospital administrators, and surgeons. Distributors were asked to immediately complete the attached response form, confirming receipt of the notice, and return a copy to Wright Medical by fax to 901-867-4788. For questions they were instructed to call 800-874-5630. For questions regarding this recall call 901-867-4788.
Quantity in Commerce 10 units
Distribution Nationwide Distribution including FL, NC, OH, IL, IN
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 = MBI and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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