Recall Z-0027-2011 ยท KWP Appliance, Fixation, Spinal Interlaminal
Zimmer Inc.
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
| Date | Oct 8, 2010 (initiated Jan 1, 2009) |
| Status | Terminated |
| Reason | The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events. |
| Root cause | Other |
| Action | The firm provided a revised surgical technique document to the Zimmer spine sales force in January, 2009. The firm will provide an Urgent Medical Device Correction notification to speedlink users through the sales force. |
| Quantity | 23,205 Units for ALL PRODUCTS IN THIS RECALL |
| Distribution | The devices are contained in implant cases stocked by Zimmer spine and made available to the Zimmer sales force for surgeries. They are not in general distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002082 | SPEEDLINK TRANSVERSE CONNECTOR Spinal Concepts, Inc., Oct 6, 2000 |