Recall Z-2702-2020— Smith & Nephew, Inc.

Name: FDA recall Z-2702-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-24

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-06-24. It names one FDA 510(k) clearance: K925573. Product: 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. Reason: 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.

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-06-24
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K925573 — ACUFEX T-BARAcufex Microsurgical, Inc.·cleared 1993-05-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.