Recall Z-0548-2022— Smith & Nephew, Inc.

Name: FDA recall Z-0548-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-04

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2022-01-04. It names one FDA 510(k) clearance: K073375. Product: INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND. Reason: The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw.

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-01-04
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K073375 — NEWDEAL TIBIAXYS SYSTEMNewdeal Sas·cleared 2008-02-21

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

INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

Reason for recall

The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw

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