Z-0454-2016Class II

Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar...

Name: Z-0454-2016 Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar...
Creator: DePuy Spine, Inc.
Published: 2015-11-20
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2015-11-20 / Terminated / root cause: design

FDA source

DePuy Spine, Inc. began a recall of Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System on 2015-11-20. FDA classified it as Class II and gives the reason as "Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0454-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-20
Posted: 2015-12-21
Terminated: 2017-07-03
Recalling firm: DePuy Spine, Inc.
Product: Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length
Root cause tag: design
FDA root cause: Device Design
Action: DePuy sent an Urgent Voluntary Product Recall Notification dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were asked to do the following: 1. Review inventory located within your facility and quarantine any products listed in this recall notice. Please contact your DePuy Synthes Spine* Sales Consultant to return any inventory located within your facility. 2. Review, complete, sign and return the attached business reply form to in accordance with the directions on the business reply form within 5 business days of receipt of this notification. 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any product listed below has been forwarded to another facility, contact that facility and provide them with this letter. 5. Keep a copy of this notice. For further questions please call (508) 828-3774
Quantity in commerce: 16 devices
Distribution: US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.
Product codes and lots: LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0454-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0454-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-21

Product code KWQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)