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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor
Recall Number Z-2225-2013
Classification Class II
Code Info 50272330 50272467 50274209 50274465 50274791 50275815 50277800 50292667 50296071 50302316 50306994 50310605 50311297 50316179 50318681 50321243 50323086 50325048 50325601 50326880 50329010 50329811 50334408 50336660 50338997 50340629 50344015 50346092 50346624 50353156 50354524 50356989 50358564 50363890 50364919 50368628 50370206 50374882 50376601 50378711 50381816 50385513 50390999 50391628 50392410 50395539 50400939 50403274 50404746 50406677 50408208 50409818 50412886 50414333 50415150 50416320 50417391 50418417 50419567 50421499 50431562 50433945 50436052 50437097 50439085 50445036 50445557 50447140 50449470 50450754 50452349 50453811 50454844 50456056 50458436 50461697
Product Distributed Qty 5873 US
Reason For Recall Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Event Detail

Event Id 66037
Product Type Devices
Status Ongoing
Recalling Firm Smith & Nephew, Inc. Endoscopy Division
City Andover
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
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