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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.

FDA Recall Z-1019-2019 · Posted None

Recalling FirmAAP Implantate Ag
Recall StatusTerminated
Product CodeKDG
Date Initiated2019-01-11
Date Terminated2022-05-26
Product Quantity25 units

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.

Firm 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.

Root Cause

Process design

Distribution Pattern

Worldwide Distribution - US Nationwide in the state of Texas and country of Germany

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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