CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report

Fang Screw Fang Plate recalled by Spinal Solutions

Spinal Solutions is recalling Fang Screw Fang Plate, distributed nationwide in the US. The recall was initiated on 20 Feb 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem # FP1220 FP1221

Quantity recalled16 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-1418-2013
FDA event ID: 64586
Recalling firm: Spinal Solutions, Murrieta, CA
Classification: Class II
Status: Terminated
Recall initiated: 20 Feb 2013
FDA classified: 27 May 2013
Reported: 5 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Spinal Implants

Timeline

20 Feb 2013	Recall initiated by company
27 May 2013	Classified by FDA	+96 days
5 Jun 2013	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

The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.

Where it was distributed

USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.

Nationwide California Maryland Mississippi Nevada Texas Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

Item # FP1220 FP1221

Where was it sold?

USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.

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

9 other products · FDA event 64586

This product is part of a recall event; the main page for the event is 45 mm Screw, Item #BG7045 Product Usage recalled by Spinal Solutions.

Reported	Class	Recall	Company	Reason	Where
5 Jun 2013	CLASS II	45 mm Screw, Item #BG7045 Product Usage recalled by Spinal Solutions	Spinal Solutions	Sterility	Nationwide
5 Jun 2013	CLASS II	Set Screw recalled by Spinal Solutions	Spinal Solutions	Sterility	Nationwide
5 Jun 2013	CLASS II	7 deg 7 deg 7 deg 7 deg 7 deg 7 deg 7 deg recalled by Spinal Solutions	Spinal Solutions	Sterility	Nationwide
5 Jun 2013	CLASS II	12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x recalled	Spinal Solutions	Sterility	Nationwide
5 Jun 2013	CLASS II	Copperhead Ibfd, Large Neutral Copperhead Ibfd recalled	Spinal Solutions	Sterility	Nationwide
5 Jun 2013	CLASS II	40 mm Rod, Item #BG1640 Product Usage recalled by Spinal Solutions	Spinal Solutions	Sterility	Nationwide
5 Jun 2013	CLASS II	50 mm Rod, Item #BG1650 Product Usage recalled by Spinal Solutions	Spinal Solutions	Sterility	Nationwide
5 Jun 2013	CLASS II	50 mm Screw, Item #BG7050 Product Usage recalled by Spinal Solutions	Spinal Solutions	Sterility	Nationwide
5 Jun 2013	CLASS II	60 mm Rod, Item #BG1660 Product Usage recalled by Spinal Solutions	Spinal Solutions	Sterility	Nationwide

Reported	Class	Recall	Company	Reason	Where
5 Jun 2013Device	CLASS II	60 mm Rod, Item #BG1660 Product Usage recalled by Spinal Solutions	Spinal Solutions	Sterility	Nationwide
5 Jun 2013Device	CLASS II	50 mm Screw, Item #BG7050 Product Usage recalled by Spinal Solutions	Spinal Solutions	Sterility	Nationwide
5 Jun 2013Device	CLASS II	50 mm Rod, Item #BG1650 Product Usage recalled by Spinal Solutions	Spinal Solutions	Sterility	Nationwide
5 Jun 2013Device	CLASS II	40 mm Rod, Item #BG1640 Product Usage recalled by Spinal Solutions	Spinal Solutions	Sterility	Nationwide
5 Jun 2013Device	CLASS II	Copperhead Ibfd, Large Neutral Copperhead Ibfd recalled	Spinal Solutions	Sterility	Nationwide

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