CLASS II Device recall · Reported 4 Dec 2013 · FDA Enforcement Report
Shortened Plug Driver recalled by Ebi
Ebi is recalling Shortened Plug Driver, distributed in California. The recall was initiated on 24 Sep 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-0411-2014
- FDA event ID
- 66654
- Recalling firm
- Ebi, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Sep 2013
- FDA classified
- 27 Nov 2013
- Reported
- 4 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Spinal Implants
Timeline
| 24 Sep 2013 | Recall initiated by company | |
| 27 Nov 2013 | Classified by FDA | +64 days |
| 4 Dec 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
Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
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
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion
Where it was distributed
US Distribution to CA
Questions about this recall
Is Shortened Plug Driver recalled?
Yes. Ebi recalled Shortened Plug Driver on 24 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0411-2014.
Why was it recalled?
Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
Which lots are affected?
Device listing # D090878 Catalog # LV00407 Lot #184090
Where was it sold?
US Distribution to CA
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 Ebi
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Biomet OrthoPak Non-invasive Bone Growth Stimulator recalled by EBI | EBI | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | 20" Lead Wires, Replacement recalled by EBI | EBI | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Biomet SpinalPak Non-invasive Spine Fusion Stimulator recalled by EBI | EBI | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | 48" Lead Wires, Replacement recalled by EBI | EBI | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Cypher MIS Screw System-The system includes screws recalled by Ebi | Ebi | Other | 9 states |
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 |