FDA recall Z-1045-2023

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008

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.

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2022-12-22
Report date: 2023-02-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1045-2023