RecallRadar

FDA Device recall Z-2222-2013

OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White

On 2013-09-25 the FDA classified a Class II recall of OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White 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-2222-2013
ClassificationClass II
Statusterminated
Initiated2013-08-06
Published2013-09-25
Last updated2026-09-13 11:53 UTC
CompanySmith And Nephew Endoscopy Division
DistributionUS

Product

OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 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
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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-2222-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.