Device product

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

Z-1674-2015

April 21, 2015

Class II

Product summary

Firm: DePuy Spine, Inc.
Event: Event 71067
Status: Terminated
Classification: Class II
Quantity: 183 devices
Official record key: device-enforcement:Z-1674-2015

Official wording

Reason: Device does not mate as intended.

Code information: LOT NUMBER: ARNDC6 & ARN DC7

Distribution pattern: US: PA and OUS: SE, BE, IT, PT

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Device does not mate as intended.