PlainRecalls
FDA Devices Moderate Class II Ongoing

TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785

Reported: October 28, 2020 Initiated: September 9, 2020 #Z-0142-2021

Product Description

TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785

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

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
263,874 (total)
Distribution
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
Location
Andover, MA

Frequently Asked Questions

What product was recalled?
TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785. Recalled by Smith & Nephew, Inc.. Units affected: 263,874 (total).
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on October 28, 2020. Severity: Moderate. Recall number: Z-0142-2021.