Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Pr
FDA device recall Z-0024-2016 · posted 2015-10-05 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 172
- Distribution
- Nationally
- Date initiated
- 2015-09-14
- Date posted
- 2015-10-05
- Date terminated
- 2016-07-15
- Location
- West Chester, PA
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