FDA recall Z-0957-2026

Smith & Nephew, Inc. · Class II · device

Product

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.

Distribution

US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN, NC, NE, NY, OK, TN, TX, UT; OUS (Foreign) to countries of: Australia, Czech Republic, Finland, France, Germany, Indonesia, Italy, Malaysia, Martinique, Mexico, Netherlands, Norway, Poland, Singapore, Switzerland.

Key facts

Status
Ongoing
Initiation date
2025-11-24
Report date
2025-12-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0957-2026