Smith & Nephew, Inc. Endoscopy Division: Medical Device Recall in 2013 - (Recall #: Z-2240-2013)

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 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor

Product Classification:

Class II

Date Initiated: August 6, 2013

Date Posted: September 25, 2013

Recall Number: Z-2240-2013

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: 314 US

Code Information:

50373721 50375642 50397595 50397598 50397604 50397607 50449548

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