Z-1670-2009

DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended...

Name: Z-1670-2009 DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended...
Creator: DePuy Spine, Inc.
Published: 2009-02-11
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2009-02-11 / Terminated / root cause: manufacturing process

FDA source

DePuy Spine, Inc. began a recall of DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended to provide immobilization and stabilization of... on 2009-02-11. The reason FDA records is "Tip of Driver may break during use". 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-1670-2009
Status: Terminated
Initiated: 2009-02-11
Posted: 2009-08-14
Terminated: 2015-07-09
Recalling firm: DePuy Spine, Inc.
Product: DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Tip of Driver may break during use
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: DePuy Spine notified direct accounts by visit and distributors by letter titled "Urgent - Voluntary Product Recall Notification". Accounts are requested to return the notification fax form and all affected product. For further questions, contact Depuy Spine at 1-800-227-6633.
Quantity in commerce: 117 units
Distribution: Nationwide Distribution -- Including states of MD, PA, NC, MO, NV, AZ, WI and CT.
Product codes and lots: Product Code: 2894-10-300; Lot Number: 1208NT.

Product code KWP

K070300Class IIExpedium Sfx Cross Connector SystemDepuy Spine, Inc. / cleared 2007-04-10

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)