Recall Z-0265-2022— Smith & Nephew, Inc.

Name: FDA recall Z-0265-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-25

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2021-10-25. It names one FDA 510(k) clearance: K162078. Product: Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.. Reason: The labels on the packages of screws were switched..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-10-25
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K162078 — EVOS Small Fragment Plating SystemSmith & Nephew, Inc.·cleared 2016-11-18

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 and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.

Reason for recall

The labels on the packages of screws were switched.

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