FDA-Device2015-06-03Class II

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

DePuy Spine, Inc.
Hazard

Device does not mate as intended.

Sold states
US: PA and OUS: SE, BE, IT, PT
Affected count
183 devices
Manufactured in
325 Paramount Dr, Raynham, MA, United States
Products
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1674-2015

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