Smith & Nephew, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1273-2020)

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 Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.

Product Classification:

Class II

Date Initiated: December 30, 2019

Date Posted: February 26, 2020

Recall Number: Z-1273-2020

Event ID: 84748

Reason for Recall:

Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.

Status: Terminated

Product Quantity: 82 distributed throughout US:AZ, ID, MO, NC, ND, NE, OK, SC, TN. 243 distributed OUS: AE, AU, CA, CH, ES, FI, JP, PR, SG. Total: 325 units

Code Information:

Batch numbers: 2010547, 2025137, 2036695, 50763859, & 50773071. Part Number 72200796. UDI 10600147.

Distribution Pattern:

Worldwide distribution US Nationwide distribution in the states of AZ, ID, MO, NC, ND, NE, OK, SC, TN, and countries of AE, AU, CA, CH, ES, FI, JP, PR, SG.

Voluntary or Mandated:

Voluntary: Firm initiated