CLASS II Device recall · Reported 30 Dec 2015 · FDA Enforcement Report

Aegis Torque Handle recalled by DePuy Spine

DePuy Spine is recalling Aegis Torque Handle, distributed in 9 states. The recall was initiated on 20 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134

Quantity recalled16 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0454-2016
FDA event ID: 72654
Recalling firm: DePuy Spine, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 20 Nov 2015
FDA classified: 21 Dec 2015
Reported: 30 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Processing Deviation
Device type: Spinal Implants

Timeline

20 Nov 2015	Recall initiated by company
21 Dec 2015	Classified by FDA	+31 days
30 Dec 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

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

Where it was distributed

US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.

California Colorado Florida Idaho Maryland Michigan North Carolina New York Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134

Where was it sold?

US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from DePuy Spine

All 36

Reported	Class	Recall	Company	Reason	Where
13 Jul 2022Device	CLASS II	EIT CIF cage, H, 8degree, L- an intervertebral body fusion recalled	DePuy Spine	Packaging Defects	Nationwide
13 Jul 2022Device	CLASS II	EIT CIF cage, H, 8degree, S- an intervertebral body fusion recalled	DePuy Spine	Packaging Defects	Nationwide
8 May 2019Device	CLASS II	Concorde Lift, Lordotic Expandable Interbody Device recalled	DePuy Spine	Other	Nationwide
8 May 2019Device	CLASS II	Concorde Lift, Expandable Interbody Device recalled by DePuy Spine	DePuy Spine	Other	Nationwide
11 Apr 2018Device	CLASS II	Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 recalled	DePuy Spine	Other	MA

Other Spinal Implants recalls

All 1,161

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as: Spinal CDS recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
30 Sep 2026Device	CLASS II	Extended Polyaxial Head, Attached Gimbal recalled	Seaspine Orthopedics	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Anterior Spine Pack recalled	Medline Industries	Other	Nationwide
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide