RecallRadar

FDA Device recall Z-2217-2013

BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture

On 2013-09-25 the FDA classified a Class II recall of BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture 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-2217-2013
ClassificationClass II
Statusterminated
Initiated2013-08-06
Published2013-09-25
Last updated2026-09-13 11:53 UTC
CompanySmith And Nephew Endoscopy Division
DistributionUS

Product

BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 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
50281125 50284266 50287760 50291931 50296472 50300113 50311609 50316176 50321099 50328710 50345983 50346630…50281125 50284266 50287760 50291931 50296472 50300113 50311609 50316176 50321099 50328710 50345983 50346630 50347152 50375169 50379044 50391248 50392390 50409415 50414558 50419568 50421350 50443184 50447005 50449127

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-2217-2013%22

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