Recall Z-2227-2013— Smith & Nephew, Inc. Endoscopy Division

Name: FDA recall Z-2227-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-06

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc. Endoscopy Division, initiated 2013-08-06, terminated 2016-04-20. It names one FDA 510(k) clearance: K082215. Product: OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor. Reason: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier..

Recalling firm: Smith & Nephew, Inc. Endoscopy Division
Classification: Class II
Status: Terminated
Initiated: 2013-08-06
Terminated: 2016-04-20
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K082215 — OSTEORAPTOR SUTURE ANCHORSmith & Nephew Inc., Endoscopy Division·cleared 2008-11-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.