Recall Z-1019-2019 ยท KDG Chisel (Osteotome)
AAP Implantate Ag
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.
| Date | Jan 11, 2019 |
| 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. |
| 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 inciden |
| Quantity | 25 units |
| Distribution | Worldwide Distribution - US Nationwide in the state of Texas and country of Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.