FDAJanuary 25, 2019device
INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Products were distributed with the incorrect instructions for use.
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.
- FDAaap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-002019-11-28
- FDAINTEGRA, Drill CS 4.0, quick coupling single use, REF 4304252019-01-25
- FDAaap 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.2019-01-11
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