CLASS II Device recall · Reported 13 Feb 2013 · FDA Enforcement Report
Synthes(R) Spine Vectra, Vectra-T recalled by Synthes USA HQ
Synthes USA HQ is recalling Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal, distributed nationwide in the US. The recall was initiated on 6 Aug 2012 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-0781-2013
- FDA event ID
- 62943
- Recalling firm
- Synthes USA HQ, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2012
- FDA classified
- 4 Feb 2013
- Reported
- 13 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 6 Aug 2012 | Recall initiated by company | |
| 4 Feb 2013 | Classified by FDA | +182 days |
| 13 Feb 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
Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.
Product as listed by the FDA
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
Where it was distributed
Nationwide Distribution-including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal recalled?
Yes. Synthes USA HQ recalled Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal on 6 Aug 2012. The recall is Class II and its status is Terminated. Recall number Z-0781-2013.
Why was it recalled?
Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.
Which lots are affected?
2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011 - Lots 5443576, 5522810, 5537042, 5557902
Where was it sold?
Nationwide Distribution-including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
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 Synthes USA HQ
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|---|---|---|---|---|---|
| Device | CLASS II | Synthes Hand Switch - Electric Pen Drive recalled by Synthes USA HQ | Synthes USA HQ | Foreign Material | Nationwide |
| Device | CLASS II | Synthes TomoFix Plates The Synthes J5606-C TomoFix recalled | Synthes USA HQ | Other | Nationwide |
| Device | CLASS II | Synthes Trochanteric Fixation Nail As part of the Synthes recalled | Synthes USA HQ | Labeling Errors | Nationwide |
| Device | CLASS II | Synthes Soft Tissue Retractor Small Extendible recalled | Synthes USA HQ | Device Malfunction | Nationwide |
| Device | CLASS II | Titanium Trochanteric Fixation Nail recalled by Synthes USA HQ | Synthes USA HQ | Other | 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 |