Recall Z-0390-2014 ยท HWC Screw, Fixation, Bone
Synthes USA HQ, Inc.
3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
| Date | Nov 26, 2013 (initiated Jul 22, 2013) |
| Status | Terminated |
| Reason | All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device. |
| Root cause | Labeling False and Misleading |
| Action | Synthes sent an Urgent Notice: Medical Device Recall letter to Sales Reps and End Users on July 22, 2013. The letter identified the affect product, problem and actions to be taken. For questions call the Recall center at 610-719-5450. |
| Quantity | 40248 |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110592 | 3.7MM/5.0MM DYNAMIC LOCKING SCREW Synthes USA, Jul 25, 2011 |