FDAOctober 20, 2015device
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
What to do
FDA enforcement status: Terminated
Brands named
pega medicalpega
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDALidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.2026-05-12
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