PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 27, 2019 Initiated: January 11, 2019 #Z-1019-2019

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.

Details

Recalling Firm
AAP Implantate Ag
Units Affected
25 units
Distribution
Worldwide Distribution - US Nationwide in the state of Texas and country of Germany
Location
Berlin, N/A

Frequently Asked Questions

What product was recalled?
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.. Recalled by AAP Implantate Ag. Units affected: 25 units.
Why was this product recalled?
There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 27, 2019. Severity: Moderate. Recall number: Z-1019-2019.