Recall Z-2583-2010 ยท MQP Spinal Vertebral Body Replacement Device
Synthes USA (HQ), Inc.
SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) The implant holder is used to place the implant into the vertebral disc space.
| Date | Jul 23, 2010 |
| Status | Terminated |
| Reason | A potential for the implant holder tip to break off and lodge in the SynFix-LR implant, which pose a potential risk to the patient. |
| Root cause | Error in labeling |
| Action | Synthes Spine Hospital sent an ' URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated August 20, 2010 to all customers. The letter described the labeling issue and actions to be taken by the customers. The customers were instructed to review the supplementary labeling provided; contact their Synthes Spine Sales Consultant to arrange for provision of the Holding Forceps (p/n 388.401) prior to each SynFix-LR procedure; and complete and return the enclosed Verification Section form to Synthes via fax at 610-251-9005 or email: FieldAction@Synthes.com. If you have any questions, please call 1 |
| Distribution | Worldwide Distribution: USA and the countries of Canada, Japan, Switzerland, Australia, Mexico, Malaysia, New Zealand, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053508 | SYNFIX-LR Synthes Spine Co.Lp, Feb 13, 2006 |