Recall Z-0957-2026— Smith & Nephew, Inc.

Name: FDA recall Z-0957-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-24

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2025-11-24. It names 2 FDA 510(k) clearances: K142948, K080358. Product: BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.. Reason: Removal of affected lot of screws due to labeling error..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-11-24
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K142948 — BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.·cleared 2015-01-13
K080358 — PLLA, HA SCREWSmith & Nephew Inc., Endoscopy Div.·cleared 2008-04-23

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

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Reason for recall

Removal of affected lot of screws due to labeling error.

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