aap Implante AG — Class II medical device recall Z-1019-2019
Terminated recall by AAP Implantate Ag, reported 2019-03-27, distributed nationwide. There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knock
| Recall number | Z-1019-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AAP Implantate Ag, Berlin, N/A, Germany |
| Recall initiated | 2019-01-11 |
| Classified | 2019-03-17 |
| Reported by FDA | 2019-03-27 |
| Terminated | 2022-05-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE |
| Quantity | 25 units |
| Reason classes | device malfunction |
| Lot numbers | I011, I012, I013, I014, I015, I016, I017 |
| Model numbers | 3000-20 |
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 for recall
There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1019-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.