Recall Z-0024-2016 ยท LXH Orthopedic Manual Surgical Instrument
Synthes (USA) Products LLC
Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
| Date | Oct 5, 2015 (initiated Sep 14, 2015) |
| Status | Terminated |
| Reason | Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal Tibia Plates are not able to be secured to the subsequent versions of these devices as intended. |
| Root cause | Device Design |
| Action | An urgent notice of medical device recall, dated September 14, 2015, was sent to end users and sales consultants to alert them to the issue and potential risks. Return of the completed response form and the affected devide was also requested. |
| Quantity | 172 |
| Distribution | Nationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.