Home / Recalls / Smith & Nephew, Inc. Endoscopy Division / Z-2237-2013

Z-2237-2013 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
1965 US

Product Description

RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 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

50268918 50273148 50273920 50275809 50275812 50282175 50291658 50293289 50296525 50296650 50298707 50305798 50305840 50312502 50312528 50314834 50340632 50343203 50349591 50351817 50358580 50371915 50376235 50387881 50390367 50394081 50396639 50396640 50396641 50399818 50403721 50405089 50412292 50415521 50416545 50418333 50445533 50447145 50454703 50456549 50460175 50460177 50461710 50469565

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-2239-2013 Class II — TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, (August 6, 2013)
  • Z-2226-2013 Class II — OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: (August 6, 2013)