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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy Mitek Lupine Loop Plus Anchor w/ Panacryl

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  Class 2 Device Recall Depuy Mitek Lupine Loop Plus Anchor w/ Panacryl see related information
Date Initiated by Firm January 27, 2012
Date Posted March 06, 2012
Recall Status1 Terminated 3 on August 05, 2015
Recall Number Z-1164-2012
Recall Event ID 61088
510(K)Number K040827  
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Product Depuy Mitek- Lupine Loop Plus Anchor w/ Panacryl
Catalog Number: 210707

The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Code Information Lot Numbers: 3382594 3404938 3443265 3474050 3513370 3551904 
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767
For Additional Information Contact Same
508-880-8100
Manufacturer Reason
for Recall		 Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
FDA Determined
Cause 2		 Process control
Action DePuy Mitek sent an Urgent Voluntary Product Recall letter dated January 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to immediately check all inventories to determine if they have any affected product. Customers were asked to refer to the instructions to report their inventory status, return and obtain replacement or credit for the product. For questions regarding this recall call 1-877-379-4871.
Quantity in Commerce 1757 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Canada, AE, Argentina, Australia, Austria,Belgium,Brazil, Bahrain, Chile, China, Columbia,Cyprus, Check Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Finland, Great Britain, Guadeloupe, Hong Kong, Hungary,Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Luxembourg,Latvia, Martinique, Montenegro, Mexico, Maylasia, Netherlands,Norway, New Zealand, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Tunisia, Turkey,Uruguay, Venezuela, and South Africa
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 = MAI and Original Applicant = DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
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