FDA Device recall Z-2216-2013
BIORAPTOR 2.9 mm Suture Anchor with 1 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 1 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-2216-2013 |
| 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 1 ULTRABRAID Suture; Part Number: 72200774 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 | 50252956 50253511 50255944 50257231 50257887 50258391 50259146 50259750 50259821 50260686 50261428 50262956…50252956 50253511 50255944 50257231 50257887 50258391 50259146 50259750 50259821 50260686 50261428 50262956 50263219 50263661 50264102 50265258 50266339 50266927 50267570 50268569 50269026 50269813 50270372 50271272 50271909 50272355 50273934 50274664 50275118 50276255 50276806 50277167 50277785 50278253 50278900 50279470 50280271 50280510 50281120 50281481 50281875 50282158 50282541 50283320 50283827 50285048 50285421 50286293 50286609 50287487 50287743 50288414 50288712 50289363 50290038 50290548 50291351 50292241 50293608 50294169 50294378 50295261 50297038 50298069 50299385 50299683 50300671 50301473 50302325 50303059 50303150 50303787 50304658 50305102 50305723 50306820 50307460 50308223 50308654 50309005 50309760 50309927 50310434 50310774 50310860 50311917 50312590 50314382 50315219 50315411 50315799 50316169 50316263 50316662 50316990 50317055 50317280 50317454 50317458 50317464 |
|---|
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-2216-2013%22
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