Recall Z-2794-2015 ยท HWC Screw, Fixation, Bone
Synthes (USA) Products LLC
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; 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 | Sep 18, 2015 (initiated Aug 11, 2015) |
| Status | Terminated |
| Reason | DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014, related to complaints of breakage located at the bottom of the screws and under the locking screw head. |
| Root cause | Labeling False and Misleading |
| Action | Synthes sent an Urgent Notices of Medical Device Recall letter, dated August 11, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to return affected devices and response forms. For further questions please call (610) 719-6500. |
| Quantity | 40038 |
| Distribution | Nationwide Distribution |
| 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 |