FDA recall Z-1806-2025

Smith & Nephew, Inc. · Class II · device

Product

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.

Distribution

Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH, NY, AL, IA, MA, NV, MO, WA, LA, TN, NC, KY, NM, NJ, AZ and the country of ZA.

Key facts

Status
Ongoing
Initiation date
2025-03-18
Report date
2025-05-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1806-2025