CLASS III Device recall · Reported 15 May 2013 · FDA Enforcement Report
Mercury Spinal System DIA 5 Straight Rod recalled by Spinal Elements
Spinal Elements is recalling Mercury Spinal System DIA 5 Straight Rod, distributed in Ohio, Pennsylvania. The recall was initiated on 17 Apr 2009 and the FDA has classified it as Class III.
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-1264-2013
- FDA event ID
- 53487
- Recalling firm
- Spinal Elements, Carlsbad, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Apr 2009
- FDA classified
- 7 May 2013
- Reported
- 15 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Spinal Implants
Timeline
| 17 Apr 2009 | Recall initiated by company | |
| 7 May 2013 | Classified by FDA | +1481 days |
| 15 May 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Where it was distributed
Distributed in OH and PA.
Questions about this recall
Is Mercury Spinal System DIA 5 Straight Rod recalled?
Yes. Spinal Elements recalled Mercury Spinal System DIA 5 Straight Rod on 17 Apr 2009. The recall is Class III and its status is Terminated. Recall number Z-1264-2013.
Why was it recalled?
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Which lots are affected?
Lot Number: 080600
Where was it sold?
Distributed in OH and PA.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Elements
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Amendia Omega Lumbar Interbody Fusion Device recalled by Spinal Elements | Spinal Elements | Other | 5 states |
| Device | CLASS III | 5 Mercury lordosed rod recalled by Spinal Elements | Spinal Elements | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Ti-Bond Marketing Literature/Labeling recalled by Spinal Elements | Spinal Elements | Other | Nationwide |
| Device | CLASS III | Mercury Spinal System DIA 5 Straight Rod recalled by Spinal Elements | Spinal Elements | Lead & Heavy Metals | OH, PA |
| Device | CLASS III | Mercury Spinal System DIA MM Lordosed Rod recalled by Spinal Elements | Spinal Elements | Lead & Heavy Metals | OH, PA |
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 |