RecallDepth

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

Company
Depuy Spine, Inc.
Recall Initiated
April 21, 2015
Posted
May 26, 2015
Terminated
October 3, 2018
Recall Number
Z-1674-2015
Quantity
183 devices
Firm Location
Raynham, MA

Reason for Recall

Device does not mate as intended.

Distribution

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

Lot / Code Info

LOT NUMBER: ARNDC6 & ARN DC7

Root Cause

Process design

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.

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