Smith & Nephew, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2702-2020)

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:

Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771

Product Classification:

Class II

Date Initiated: June 24, 2020

Date Posted: August 5, 2020

Recall Number: Z-2702-2020

Event ID: 85984

Reason for Recall:

The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve

Status: Ongoing

Product Quantity: 137 Lot 2042492; 130 Lot 2049408

Code Information:

Lot Number: 2042492 8/28/20 Expanded Recall- Lot number 2049408

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the state of CO and the countries of AT, BE, CH, CL, DE, DK, ES, FR, GB, IT. Expanded 8/28/20 recall: 2nd Field Action: AU, CH, DE, FR, GB, IT, NL, PL, PT, & ZA

Voluntary or Mandated:

Voluntary: Firm initiated