Smith & Nephew, Inc. Endoscopy Division: Medical Device Recall in 2013 - (Recall #: Z-2227-2013)

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:

OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor

Product Classification:

Class II

Date Initiated: August 6, 2013

Date Posted: September 25, 2013

Recall Number: Z-2227-2013

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: 4946 US

Code Information:

50366964 50366974 50366982 50366987 50366991 50370758 50370941 50370943 50371293 50376477 50387447 50392962 50394696 50397924 50400302 50400308 50408067 50414256 50415787 50417207 50419579 50425118 50428815 50429654 50431732 50435075 50435211 50444669 50445035 50445761 50445877 50450950 50458418 50458435

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