Home / Recalls / Smith & Nephew, Inc. Endoscopy Division / Z-2234-2013

Z-2234-2013 Class II Terminated

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

FDA device recall Z-2234-2013 was initiated by Smith & Nephew, Inc. Endoscopy Division on August 6, 2013 and is designated Class II. Reason for recall: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. The recall status is terminated (terminated April 20, 2016). Affected quantity: N/A.

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: N/A

Product Description

TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 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

50324716 50324717 50326836 50336720 50336769 50337108 50337111 50339644 50339652 50339655 50339836 50340060 50341066 50341289 50341609 50341853 50342712 50344393 50345532 50349940 50375176 50377968 50378734 50380398 50382028 50385516 50386564 50387848 50391713 50392430 50395097 50395980 50396847 50399973 50400923 50402846 50405227 50406208 50406714 50408995 50410652 50411391 50412536 50415225 50415871 50416543 50417398 50428649 50429274 50429621 50429622 50429871 50436765 50436775 50437663 50440391 50443629 50446032 50446451 50446454 50446455 50447009 50447010 50453524

Other recalls by Smith & Nephew, Inc. Endoscopy Division

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-2045-2014 Class II — SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 (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-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-2231-2013 Class II — TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Pa (August 6, 2013)