RecallRadar

FDA Device recall Z-0548-2022

INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

On 2022-02-09 the FDA classified a Class II recall of INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND by Smith And Nephew, citing the affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0548-2022
ClassificationClass II
Statusongoing
Initiated2022-01-04
Published2022-02-09
Last updated2026-09-13 11:56 UTC
CompanySmith And Nephew
DistributionUS

Product

INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

Reason

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

Identifiers

code_infoUDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0548-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.