FDA-Device2023-02-08Class II
MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
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.
Sold states
US Nationwide distribution.
Affected count
420 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1045-2023Don't want to check this manually?
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