Recall Z-0139-2013 ยท HWC Screw, Fixation, Bone
Encore Medical, Lp
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
| Date | Oct 25, 2012 (initiated Sep 28, 2012) |
| Status | Terminated |
| Reason | A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on |
| Root cause | Labeling mix-ups |
| Action | Encore Medical sent a Urgent Field Safety Notice dated September 28, 2012, to all affected customers. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please contact Customer Service to place a replacement order and receive an RMA number. Return all affected devices using the RMA number. For further questions please call (512) 834-6255 |
| Quantity | 1 unit |
| Distribution | Nationwide Distribution only to CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931665 | 6.5 MM CANCELLOUS BONE SCREW Encore Orthopedics, Inc., Feb 17, 1994 |