RecallRadar

FDA Device recall Z-2227-2013

OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black

On 2013-09-25 the FDA classified a Class II recall of OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black by Smith And Nephew Endoscopy Division, citing pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2227-2013
ClassificationClass II
Statusterminated
Initiated2013-08-06
Published2013-09-25
Last updated2026-09-13 11:53 UTC
CompanySmith And Nephew Endoscopy Division
DistributionUS

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.

Identifiers

code_info
50366964 50366974 50366982 50366987 50366991 50370758 50370941 50370943 50371293 50376477 50387447 50392962…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2227-2013%22

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