FDAJanuary 11, 2019device
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
What to do
FDA enforcement status: Terminated
Brands named
aap implantate agaapaap implantate
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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