Z-1019-2019Class II

aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20

Name: Z-1019-2019 aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20
Creator: AAP Implantate Ag
Published: 2019-01-11
License: https://open.fda.gov/license/

AAP Implantate AG / initiated 2019-01-11 / Terminated / root cause: manufacturing process

FDA source

AAP Implantate Ag began a 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 plates and screws as... on 2019-01-11. FDA classified it as Class II and gives the reason as "There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1019-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-11
Posted: 2019-03-18
Terminated: 2022-05-26
Recalling firm: AAP Implantate AG
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.
Product code: KDG Chisel (Osteotome)
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm initiated the recall on 01/11/2019 by email and fax. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Please immediately remove all products/articles of the affected lot numbers from your stock to secure any further use. 2. With this letter you will receive a confirmation form, please complete it completely, sign it and send it back to us immediately after receiving this information. If you do not have any affected products, please fill out the confirmation form and fax lt to 0049 (0) 30 750 19 111 or mail it to [email protected]. 3. Please return all affected products/articles immediately to us.
Quantity in commerce: 25 units
Distribution: Worldwide Distribution - US Nationwide in the state of Texas and country of Germany
Product codes and lots: Lot Numbers: I011, I012, I013, I014, I015, I016, I017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1019-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1019-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-27	2019-03-17

Product code KDG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)