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U.S. Department of Health and Human Services

Class 2 Device Recall BIORAPTOR 2.9 mm Suture Anchor

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 Class 2 Recall
BIORAPTOR 2.9 mm Suture Anchor
see related information
Date Posted September 17, 2013
Recall Status1 Open
Recall Number Z-2218-2013
Recall Event ID 66037
Premarket Notification
510(K) Number
K031685 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor
Code Information 50253115 50253116 50253563 50258921 50259836 50261046 50261482 50266078 50266098 50266396 50266957 50270377 50271281 50273022 50274567 50281658 50291542 50293283 50298902 50302160 50304442 50308346 50310770 50323628 50328862 50348760 50349091 50350411 50353298 50359945 50360003 50361170 50361752 50364587 50366305 50380819 50382582 50386154 50387219 50387852 50388184 50388737 50389115 50389772 50417524 50452589 50464571
Recalling Firm/
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover, Massachusetts 01810-1031
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Albert A. Pytka
978-749-1073
Manufacturer Reason
for Recall
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action Smith&Nephew sent an Urgent Product Recall Notification letter dated August 6, 2013, via Federal Express to all affected customers. Addendum customer letters for 4 additional part numbers were sent via Federal Express on August 19, 2013, The letters identified the product, the problem, and the action to be taken by the customer. Customers were asked to inspect their inventory, locate unused devices and quarantine them. Customers were also asked to complete the last three columns in the inventory Return Certification form indicating the quantities that need to be returned, and include their contact information in the spaces provided. Customers were instructed to contact Smith & Nephew's Demo Service Departmentat 800-343-5717 for a Return Authorization (RA#), and provide the information response form. Replacement product would be provided. For questions regarding this recall call 978-749-1073.
Quantity in Commerce 725 US
Distribution Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
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 = HWC and Original Applicant = SMITH & NEPHEW, INC.
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