Smith & Nephew, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0155-2021)

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:

TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602

Product Classification:

Class II

Date Initiated: September 9, 2020

Date Posted: October 28, 2020

Recall Number: Z-0155-2021

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: 2013151 2013152 2013903 2016145 2017808 2018788 2019884 2019885 2025277 2027457 2031003 2031002 2031054 2031055 2033509 2033508 2034401 2038771 2042570 2042752 2048296 2049809 2050955 2053788 2056330 2056872

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