Device product
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.
Z-1019-2019
Product summary
- Event
- Event 82159
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 units
- Official record key
device-enforcement:Z-1019-2019
Official wording
Reason: There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
Code information: Lot Numbers: I011, I012, I013, I014, I015, I016, I017
Distribution pattern: Worldwide Distribution - US Nationwide in the state of Texas and country of Germany
Derived failure modes
-
Unknown
There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.