Recall Z-0275-2016 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Medacta Usa
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
| Date | Nov 14, 2015 (initiated Apr 17, 2015) |
| Status | Terminated |
| Reason | Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws. |
| Root cause | Employee error |
| Action | On 4/16/15 all distributors with recalled product were immediately notified of the recall by phone. On 4/20/15, all distributors were further notified of the recall via email. The URGENT MEDICAL DEVICE RECALL letter dated 4/17/2015 the firm described the initiation of a recall for regarding the GMK HINGE Tibial Augmentation Size 4-10mm Reference 02.09TA410 / Lot 145129. The firm provided the following recall actions to be performed: 1.Check your inventory for the device listed above. If you find it, IMMEDIATELY place it in quarantine and DO NOT use it in surgery. 2.If you have further dis |
| Quantity | 4 units (US) |
| Distribution | Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130299 | GMK HINGE Medacta International, Aug 15, 2013 |