Class II — AAP Implantate Ag
| Recalling firm | AAP IMPLANTATE AG |
|---|---|
| Registered facility | AAP IMPLANTATE AG (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate. |
| 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. |
| Quantity | 25 units |
| Distribution | Worldwide Distribution - US Nationwide in the state of Texas and country of Germany |
| Initiated | 2019-01-11 |
| Classified | 2019-03-17 |
| Terminated | 2022-05-26 |
| Recall number | Z-1019-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — AAP Implantate Ag (Z-1019-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82159/
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