• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor
Recall Number Z-2239-2013
Classification Class II
Code Info 50373722 50397580 50397597 50397602 50397606 50414780 50418109 50431745 50431893 50432157 50438518 50438520 50447115 50447117 50447120 50448228 50449526 50449671 50450004 50454012 50454109 50456362 50459638 50460185 50462233 50468656 50469160 50469533
Product Distributed Qty 2038 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.
-
-