FDA DeviceClass IINotable

FDA Recall: Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-

Date: 2026-07-01
Brand: Acumed LLC
Category: Medical Device
FDA Class: Class II

Description

Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

Hazard

Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

Remedy

5,272 units

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