Smith & Nephew, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0169-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705

Product Classification:

Class II

Date Initiated: September 9, 2020

Date Posted: October 28, 2020

Recall Number: Z-0169-2021

Event ID: 86462

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

Status: Ongoing

Product Quantity: 263,874 (total)

Code Information:

Batch Numbers: 2013957 2013995 2013996 2016209 2016207 2017775 2017860 2018647 2019852 2019853 2021462 2023240 2023345 2024841 2024742 2026562 2025370 2025438 2027467 2025207 2027434 2027500 2027405 2029350 2029351 2030952 2031022 2031088 2031089 2031156 2033536 2034426 2035500 2034498 2037191 2037151 2039451 2039609 2041070 2042597 2042777 2048390 2048391 2049913 2051216 2049914 2051654 2051655 2051656 2051657 2053912 2053913 2056080 2056081 2056426

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

Voluntary or Mandated:

Voluntary: Firm initiated