Smith & Nephew, Inc. Endoscopy Division: Medical Device Recall in 2013 - (Recall #: Z-2219-2013)

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:

BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor

Product Classification:

Class II

Date Initiated: August 6, 2013

Date Posted: September 25, 2013

Recall Number: Z-2219-2013

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: 240 US

Code Information:

50257249 50266395 50266956 50273021 50274566 50292663 50298060 50310769 50312085 50312489 50314911 50319308 50320226 50365776 50366000 50372062 50372899 50373577 50430178 50430381 50432333 50433339 50435314 50437523

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