FDANovember 28, 2019device
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.
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.
- FDAINTEGRA, Drill CS 4.5, quick coupling single use, REF 4304532019-01-25
- 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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