Home / Recalls / Smith & Nephew, Inc. Endoscopy Division / Z-2226-2013

Z-2226-2013 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
4452 US

Product Description

OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 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

50272335 50272468 50274466 50274792 50275817 50278112 50282209 50283021 50286518 50286657 50286925 50288725 50290551 50291360 50294564 50295956 50296887 50298073 50301797 50307182 50309401 50309926 50310781 50312498 50314440 50319909 50320249 50322931 50323640 50325599 50326068 50329810 50329975 50333958 50335745 50338377 50341064

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-2220-2013 Class II — OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Num (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-2222-2013 Class II — OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Bi (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-2231-2013 Class II — TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Pa (August 6, 2013)