FDANovember 30, 2012device

Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-steril...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification

What to do

FDA enforcement status: Terminated

Brands named

biomet spinebiomet

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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