FDA Device recall Z-1019-2019
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone pl…
- FDA Device
- Class II
- terminated
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone pl… by Aap Implantate Ag, citing there is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1019-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-11 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Aap Implantate Ag |
| Distribution | US |
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.
Identifiers
| code_info | Lot Numbers: I011, I012, I013, I014, I015, I016, I017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1019-2019%22
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