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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 Device Recall BIORAPTOR 2.9 mm Suture Anchor see related information
Date Initiated by Firm August 06, 2013
Date Posting Updated September 17, 2013
Recall Status1 Terminated 3 on April 20, 2016
Recall Number Z-2218-2013
Recall Event ID 66037
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 MA 01810-1031
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
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 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 = SMITH & NEPHEW, INC.
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