Recall Z-1348-2009 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
Synthes Spine
Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.
| Date | Jun 10, 2009 (initiated Feb 10, 2009) |
| Status | Terminated |
| Reason | Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information related to use of the Torque Limiting Attachment during screw insertion and final tightening. |
| Root cause | Labeling design |
| Action | All affected Synthes Spine Sales Consultants were notified of the Labeling Correction via email on February 10, 2009. They were instructed to review changes with their surgeons. They were supplied with an electronic version of the corrected Technique Guide on March 11, 2009. All affected Synthes Sales Consultants and Customers were notified of this labeling change via distribution of the updated Technique Guide and a notification letter. This packet was sent via USPS certified mail on March 26, 2009. To ensure a broad and accurate distribution of notification, affected consultants and cust |
| Quantity | 1766 units |
| Distribution | Distributed Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072981 | SYNTHES ZERO-P Synthes Spine Co.Lp, Feb 11, 2008 |