Z-0172-2021 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

HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708

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: 2014002 2016196 2017814 2020051 2021388 2023272 2024724 2026266 2024759 2025289 2027469 2030955 2031023 2033400 2035501 2036291 2038328 2039263 2048404 2049924 2051020 2053921 2056432 2057402