FDAJanuary 31, 2017device
PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820.350 lot 5919005 is a 12 mm Strut. The item etched and labeled as 12 mm Strut 03.820.352 lot 5919006 is a 10 mm Strut.
What to do
FDA enforcement status: Terminated
Brands named
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Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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