Z-0148-2021 Class II Ongoing

Recalled by Smith & Nephew, Inc. — Andover, MA

Recall Details

Product Type
Devices
Report Date
October 28, 2020
Initiation Date
September 9, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
263,874 (total)

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

Code Information

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