EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER
FDA device recall Z-1674-2015 · posted 2015-05-26 · Terminated
Recall details
- Recalling firm
- DePuy Spine, Inc.
- Reason for recall
- Device does not mate as intended.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 183 devices
- Distribution
- US: PA and OUS: SE, BE, IT, PT
- Date initiated
- 2015-04-21
- Date posted
- 2015-05-26
- Date terminated
- 2018-10-03
- Location
- Raynham, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPEDIUM Spine System/Synapse System (K142460) | Johnson and Johnson | 2014-10-01 |
| EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM (K111136) | Depuy Spine, Inc. | 2012-06-14 |
| EXPEDIUM SPINE SYSTEM (K101070) | Medos International SARL | 2010-08-31 |