Recall Z-1019-2019— AAP Implantate Ag
Class II · Terminated
Class II FDA medical device recall by AAP Implantate Ag, initiated 2019-01-11, terminated 2022-05-26. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate..
- Recalling firm
- AAP Implantate Ag
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-01-11
- Terminated
- 2022-05-26
- Firm location
- Berlin, N/A, Germany
Product description
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.
Reason for recall
There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
Data sourced from openFDA. This site is unofficial and independent of the FDA.