Recall Z-1681-2014 ยท MQP Spinal Vertebral Body Replacement Device
Synthes, Inc.
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).
| Date | Jun 2, 2014 (initiated Apr 8, 2014) |
| Status | Terminated |
| Reason | Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height. |
| Root cause | Process control |
| Action | Synthes sent an Urgent Notice: Medical Device Recall letter dated April 8, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action Required: Synthes has record that your facility has the product(s) subject to this recall. Synthes asks that you review your inventory and immediately remove the affected lots from stock. If you DO have any of the identified devices, please take the following steps: Contact your local Synthes Spine Sales Consultant to return any inventory located within your facility. Complete th |
| Quantity | 3 |
| Distribution | US Distribution including the states of FL, NJ and MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103320 | SYNTHES XRL Synthes Spine Co.Lp, Oct 20, 2011 |