Z-1674-2015Class II

EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150...

Name: Z-1674-2015 EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150...
Creator: DePuy Spine, Inc.
Published: 2015-04-21
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2015-04-21 / Terminated / root cause: manufacturing process

FDA source

DePuy Spine, Inc. began a recall of EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467 on 2015-04-21. FDA classified it as Class II and gives the reason as "Device does not mate as intended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1674-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-21
Posted: 2015-05-26
Terminated: 2018-10-03
Recalling firm: DePuy Spine, Inc.
Product: EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Device does not mate as intended.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 183 devices
Distribution: US: PA and OUS: SE, BE, IT, PT
Product codes and lots: LOT NUMBER: ARNDC6 & ARN DC7

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1674-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1674-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-26

Product code NKB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)