CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report
12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x recalled
Spinal Solutions is recalling 12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x, 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
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-1415-2013
- 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
12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm 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 CaliforniaMarylandMississippiNevadaTexasWisconsin
Stores named: Online Retailers
Questions about this recall
Is 12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x recalled?
Yes. Spinal Solutions recalled 12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x on 20 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-1415-2013.
Why was it recalled?
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.
Which lots are affected?
Item # 10227-008 10227-009 10227-010 10227-011 10227-012 10227-013 10227-014
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 21 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 Spinal Solutions
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 60 mm Rod, Item #BG1660 Product Usage recalled by Spinal Solutions | Spinal Solutions | Sterility | Nationwide |
| Device | CLASS II | 50 mm Screw, Item #BG7050 Product Usage recalled by Spinal Solutions | Spinal Solutions | Sterility | Nationwide |
| Device | CLASS II | 50 mm Rod, Item #BG1650 Product Usage recalled by Spinal Solutions | Spinal Solutions | Sterility | Nationwide |
| Device | CLASS II | 40 mm Rod, Item #BG1640 Product Usage recalled by Spinal Solutions | Spinal Solutions | Sterility | Nationwide |
| Device | 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |