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U.S. Department of Health and Human Services

Class 2 Device Recall Lupine BR Anchor w/Orthocord

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 Class 2 Recall
Lupine BR Anchor w/Orthocord
see related information
Date Posted September 17, 2008
Recall Status1 Terminated on October 02, 2008
Recall Number Z-1810-2008
Recall Event ID 47897
Premarket Notification
510(K) Number
K070925 
Product Classification Staple, Fixation, Bone - Product Code JDR
Product Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided Composite Suture, violet 36" (91cm) Size 2 (5metric) eyelet loop. Made in Switzerland; Sterile. The Lupine BR Anchor System is indicated for use in soft tissue bone fixation.
Code Information Catalog Number 210711 Lot Number 3069512
Recalling Firm/
Manufacturer
DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham, Massachusetts 02767
For Additional Information Contact Kimberly Soter
508-977-3964
Manufacturer Reason
for Recall
Lupine BR Anchor w/Orthocord was assembled with an incorrect suture configuration. The suture loop was not assembled at the distal end of the anchor. It was only threaded through the suture hole in the anchor. Risk associated with incorrect suture configuration include premature breakage.
FDA Determined
Cause 2
TRAINING: Employee Error
Action DePuy Mitek notified customers by letter dated April 29, 2008 titled Urgent: Voluntary Medical Device Recall Letter asking consignees to isolate and do not use product and to return any of the identified product to DePuy Mitek using enclosed prepaid Federal Express shipping labels and to include a photocopy of the completed Business Reply Form. The firm is asking customers to complete the Business Reply Form with a self addressed, stamped envelope indicating level of inventory of the affected product and to return for immediate delivery of replacement product. If you have any questions contact DePuy Mitek Customer Service directly at 1-800-382-4682.
Quantity in Commerce 105 units
Distribution Class II Recall - Worldwide Distribution --- USA including states of CA, NY, MA, NV, OH, TX, TN, MD, and countries of France, UK, Canada, Spain.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JDR and Original Applicant = DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
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