MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
FDA Recall #Z-1047-2023 — Class II — December 22, 2022
Product Description
MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
Reason for Recall
The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.
Recalling Firm
MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
190 units
Distribution
US Nationwide distribution.
Code Information
GTIN 10888277699113, Lot Number ?
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated