Smith & Nephew, Inc. Endoscopy Division: Medical Device Recall in 2013 - (Recall #: Z-2234-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 6, 2013

Date Posted: September 25, 2013

Recall Number: Z-2234-2013

Event ID: 66037

Reason for Recall:

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Status: Terminated

Product Quantity: N/A

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated