FDA recall Z-0548-2022

Smith & Nephew, Inc. · Class II · device

Product

INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

Reason for recall

The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw

Distribution

US Nationwide distribution in the states of CA and OH.

Key facts

Status: Ongoing
Initiation date: 2022-01-04
Report date: 2022-02-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0548-2022