Home / Recalls / Smith & Nephew, Inc. Endoscopy Division / Z-2049-2014

Z-2049-2014 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
July 23, 2014
Initiation Date
June 2, 2014
Termination Date
September 15, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
763 units

Product Description

SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue

Reason for Recall

Sterility of device is compromised due to breach in sterile barrier

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.

Code Information

Lot Numbers: 50478984,50485736, 50485737, 50485738, 50487831, 50491901, 50493684

Other recalls by Smith & Nephew, Inc. Endoscopy Division

  • Z-2046-2014 Class II — SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: (June 2, 2014)
  • Z-2047-2014 Class II — SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastene (June 2, 2014)
  • Z-2045-2014 Class II — SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 (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-2220-2013 Class II — OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Num (August 6, 2013)
  • Z-2238-2013 Class II — TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue (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)
  • Z-2231-2013 Class II — TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Pa (August 6, 2013)
  • Z-2223-2013 Class II — OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part N (August 6, 2013)