Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
FDA Recall Z-0024-2016 · Posted 2015-10-05
Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeLXH
Date Initiated2015-09-14
Date Terminated2016-07-15
Product Quantity172
Reason for Recall
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationally
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.