Recall Z-1674-2015 ยท NKB Thoracolumbosacral Pedicle Screw System
DePuy Spine, Inc.
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
| Date | May 26, 2015 (initiated Apr 21, 2015) |
| Status | Terminated |
| Reason | Device does not mate as intended. |
| Root cause | Process design |
| Action | Consignees were notified of the recall via letter sent by overnight shipment for delivery on April 23, 2015. The letter instructs distributors and customers to review their inventory and return any products with the listed lot number. |
| Quantity | 183 devices |
| Distribution | US: PA and OUS: SE, BE, IT, PT |
| FDA record | Open on fda.gov |