FDA Device recall Z-2215-2013
BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture
- 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 with 2 ULTRABRAID 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2215-2013 |
| 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 with 2 ULTRABRAID Suture; Part Number: 72200775 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 | 50252371, 50252817, 50252818, 50253051, 50253556, 50254393, 50255140, 50255943, 50257230, 50257886, 50258390, 50258813,…50252371, 50252817, 50252818, 50253051, 50253556, 50254393, 50255140, 50255943, 50257230, 50257886, 50258390, 50258813, 50259145, 50259748, 50259820, 50260127, 50261934, 50263317, 50263909, 50264101, 50264417, 50264775, 50265257, 50265457, 50265935, 50266338, 50266709, 50266926, 50267287, 50267297, 50267742, 50268009, 50268284, 50268801, 50269502, 50269812, 50270227, 50270716, 50271271, 50271608, 50271908, 50272544, 50273015, 50273358, 50273640, 50273933, 50274557, 50274799, 50275368, 50276253, 50276254, 50276805, 50277029, 50277294, 50277527, 50277929, 50278456, 50278571, 50278899, 50279282, 50279628, 50279887, 50280270, 50280509, 50280951, 50281119, 50281654, 50281988, 50282538, 50282785, 50283315, 50283661, 50284261, 50284507, 50285047, 50285232, 50286292, 50286603, 50287484, 50287742, 50287951, 50288412, 50288413, 50288709, 50288711, 50289018, 50289361, 50289598, 50290037,50290863, 50291536, 50291656, 50292239, 50292240, 50292919, 50293285, 50293609, 50293897 50294168, 5 |
|---|
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-2215-2013%22
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