RecallRadar

FDA Device recall Z-0148-2021

OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991

On 2020-10-28 the FDA classified a Class II recall of OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991 by Smith And Nephew, citing product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0148-2021
ClassificationClass II
Statusongoing
Initiated2020-09-09
Published2020-10-28
Last updated2026-09-13 11:55 UTC
CompanySmith And Nephew
DistributionUS

Product

OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991

Reason

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Identifiers

code_info
Batch Numbers: 2012767 2013997 2016120 2017772 2018792 2019839 2021494 2022257 2024709 2025285 2027451 2027…Batch Numbers: 2012767 2013997 2016120 2017772 2018792 2019839 2021494 2022257 2024709 2025285 2027451 2027481 2030907 2030908 2031041 2033235 2033236 2034376 2034377 2034378 2035450 2036270 2049647 2049648 2053756 2049649 2050880 2050881 2056052 2056053

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0148-2021%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.