Home / Recalls / Smith & Nephew, Inc. Endoscopy Division / Z-2227-2013

Z-2227-2013 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
4946 US

Product Description

OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 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

50366964 50366974 50366982 50366987 50366991 50370758 50370941 50370943 50371293 50376477 50387447 50392962 50394696 50397924 50400302 50400308 50408067 50414256 50415787 50417207 50419579 50425118 50428815 50429654 50431732 50435075 50435211 50444669 50445035 50445761 50445877 50450950 50458418 50458435

Other recalls by Smith & Nephew, Inc. Endoscopy Division

  • Z-2049-2014 Class II — SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixa (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-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-2238-2013 Class II — TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue (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-2231-2013 Class II — TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Pa (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)
  • Z-2226-2013 Class II — OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: (August 6, 2013)