Recall Z-1806-2025— Smith & Nephew, Inc.

Name: FDA recall Z-1806-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-18

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2025-03-18. It names 2 FDA 510(k) clearances: K210980, K092748. Product: META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690. Reason: Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-03-18
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

2 on FDA's record

K210980 — Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc.·cleared 2022-11-14
K092748 — SURESHOT TAN NAILS AND ACCESSORIESSmith & Nephew, Inc.·cleared 2010-04-26

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

META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

Reason for recall

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

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