PlainRecalls
FDA Devices Moderate Class II Terminated

EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467

Reported: June 3, 2015 Initiated: April 21, 2015 #Z-1674-2015

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.

Details

Recalling Firm
DePuy Spine, Inc.
Units Affected
183 devices
Distribution
US: PA and OUS: SE, BE, IT, PT
Location
Raynham, MA

Frequently Asked Questions

What product was recalled?
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467. Recalled by DePuy Spine, Inc.. Units affected: 183 devices.
Why was this product recalled?
Device does not mate as intended.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 3, 2015. Severity: Moderate. Recall number: Z-1674-2015.