CLASS II Device recall · Reported 30 Jan 2013 · FDA Enforcement Report

Viper Poly Screw 5.5 8 Tl Product recalled by DePuy Spine

DePuy Spine is recalling Viper Poly Screw 5.5 8 Tl, distributed nationwide in the US. The recall was initiated on 7 Nov 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Quantity recalled34 units

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-0705-2013
FDA event ID: 63665
Recalling firm: DePuy Spine, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 7 Nov 2012
FDA classified: 23 Jan 2013
Reported: 30 Jan 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

7 Nov 2012	Recall initiated by company
23 Jan 2013	Classified by FDA	+77 days
30 Jan 2013	Published in enforcement report	+7 days

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

Reason for recall

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Product as listed by the FDA

DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.

Where it was distributed

Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.

Nationwide Arizona California Florida Hawaii Illinois Maryland Michigan Missouri North Carolina Tennessee Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

All lots

Where was it sold?

Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.

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.

Other products in this recall event

8 other products · FDA event 63665

This product is part of a recall event; the main page for the event is Viper Poly Screw 5.5 8 Tl Product recalled by DePuy Spine.

Reported	Class	Recall	Company	Reason	Where
30 Jan 2013	CLASS II	Viper Poly Screw 5.5 8 Tl Product recalled by DePuy Spine	DePuy Spine	Other	Nationwide
30 Jan 2013	CLASS II	Viper Poly Screw 5.5 10 Tl Product recalled by DePuy Spine	DePuy Spine	Other	Nationwide
30 Jan 2013	CLASS II	Viper Poly Screw 5.5 8 Tl Product recalled by DePuy Spine	DePuy Spine	Other	Nationwide
30 Jan 2013	CLASS II	Viper Poly Screw 5.5 10X100MM Tl Product recalled by DePuy Spine	DePuy Spine	Other	Nationwide
30 Jan 2013	CLASS II	Viper Poly Screw 5.5 9 Tl Product recalled by DePuy Spine	DePuy Spine	Other	Nationwide
30 Jan 2013	CLASS II	Viper Poly Screw 5.5 9 Tl Product recalled by DePuy Spine	DePuy Spine	Other	Nationwide
30 Jan 2013	CLASS II	Viper Poly Screw 5.5 9 Tl Product recalled by DePuy Spine	DePuy Spine	Other	Nationwide
30 Jan 2013	CLASS II	Viper Poly Screw 5.5 10 Tl Product recalled by DePuy Spine	DePuy Spine	Other	Nationwide

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 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide