Z-1674-2015 Class II Terminated
FDA device recall Z-1674-2015 was initiated by DePuy Spine, Inc. on April 21, 2015 and is designated Class II. Reason for recall: Device does not mate as intended. The recall status is terminated (terminated October 3, 2018). Affected quantity: 183 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2015
- Initiation Date
- April 21, 2015
- Termination Date
- October 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 183 devices
Product Description
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
Reason for Recall
Device does not mate as intended.
Distribution Pattern
US: PA and OUS: SE, BE, IT, PT
Code Information
LOT NUMBER: ARNDC6 & ARN DC7