FDA Device recall Z-2219-2013
BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2219-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-06 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smith And Nephew Endoscopy Division |
| Distribution | US |
Product
BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 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 | 50257249 50266395 50266956 50273021 50274566 50292663 50298060 50310769 50312085 50312489 50314911 50319308…50257249 50266395 50266956 50273021 50274566 50292663 50298060 50310769 50312085 50312489 50314911 50319308 50320226 50365776 50366000 50372062 50372899 50373577 50430178 50430381 50432333 50433339 50435314 50437523 |
|---|
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-2219-2013%22
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