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MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
Recalled February 8, 2023 · FDA recall Z-1045-2023 · MEDLINE INDUSTRIES, LP - Northfield
Hazard
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. · FDA Class II
Units
420 units
Sold at
US Nationwide distribution.
Description
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.
Product
MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →