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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 TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor
Recall Number Z-2233-2013
Classification Class II
Code Info 50324714 50324959 50325405 50336718 50336766 50337107 50337110 50339396 50339650 50339654 50339835 50340055 50341065 50341288 50341608 50341852 50341974 50343277 50344392 50345531 50346096 50349836 50350192 50351792 50355983 50356629 50357082 50358377 50358556 50359999 50360659 50361740 50362632 50363174 50363872 50366312 50367556 50368583 50369516 50370078 50370505 50371296 50371908 50372043 50372901 50373581 50376024 50376595 50377415 50378045 50378652 50379636 50379935 50381013 50381052 50382145 50383363 50384738 50384957 50385695 50388023 50388427 50388915 50390006 50390936 50391241 50391607 50392270 50392402 50394175 50394700 50395079 50395329 50395678 50396196 50397457 50399965 50400926 50401256 50402972 50403490 50404762 50405432 50405695 50406373 50406776 50407574 50410247 50410909 50411608 50413138 50413770 50414757 50415220 50415662 50416307 50416797 50417199 50417996 50420510 50421494 50421722 50429267 50429347 50429634 50429635 50430369 50433008 50433009 50433120 50433338 50438321 50438322 50438923 50438981 50438982 50440714 50441083 50444410 50446345 50446447 50446997 50448199 50449437 50449827 50450459 50450942 50451511 50451937 50456336 50457052 50457924 50458755 50459278 50459634 50459731 50462225 50467497
Product Distributed Qty 7148 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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