Home / Recalls / Smith & Nephew, Inc. Endoscopy Division / Z-2235-2013

Z-2235-2013 Class II Terminated

Recalled by Smith & Nephew, Inc. Endoscopy Division — Andover, MA

Recall Details

Product Type
Devices
Report Date
September 25, 2013
Initiation Date
August 6, 2013
Termination Date
April 20, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1308 US

Product Description

TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor

Reason for Recall

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

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.

Code Information

50325164 50326837 50336721 50336771 50339645 50339841 50341067 50341975 50344394 50349837 50350415 50351794 50359331 50363876 50368160 50370201 50372046 50375166 50377788 50378916 50380676 50381053 50388605 50392271 50392403 50395799 50403938 50411076 50417379 50422358 50433010 50433121 50438323 50448200 50460082

Other recalls by Smith & Nephew, Inc. Endoscopy Division

  • Z-2045-2014 Class II — SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 (June 2, 2014)
  • Z-2047-2014 Class II — SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastene (June 2, 2014)
  • Z-2046-2014 Class II — SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: (June 2, 2014)
  • Z-2048-2014 Class II — SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 722038 (June 2, 2014)
  • Z-2049-2014 Class II — SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixa (June 2, 2014)
  • Z-2223-2013 Class II — OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part N (August 6, 2013)
  • Z-2220-2013 Class II — OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Num (August 6, 2013)
  • Z-2234-2013 Class II — TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number (August 6, 2013)
  • Z-2222-2013 Class II — OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Bi (August 6, 2013)
  • Z-2237-2013 Class II — RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Nu (August 6, 2013)