CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report
Vector TAS Modular Driver, a manual driver recalled by Ormco/Sybronendo
Ormco/Sybronendo is recalling Vector TAS Modular Driver, a manual driver for Vector TAS dental screws, distributed nationwide in the US. The recall was initiated on 12 Dec 2011 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-0205-2013
- FDA event ID
- 63412
- Recalling firm
- Ormco/Sybronendo, Glendora, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Dec 2011
- FDA classified
- 5 Nov 2012
- Reported
- 14 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Dental Devices
Timeline
| 12 Dec 2011 | Recall initiated by company | |
| 5 Nov 2012 | Classified by FDA | +329 days |
| 14 Nov 2012 | 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 Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130¿C. The correct sterilization temperature should be listed as 132¿C and/or 270¿F.
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
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Where it was distributed
Worldwide distribution, including Nationwide (USA) and the countries of Canada, Austria, Belgium, Bulgaria, Switzerland, Germany, Denmark, France, Estonia, Spain, Finland, Iceland, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Luxembourg, Netherlands, Monaco, Poland, Romania, Serbia, Slovenia, Turkey, Jersey, and Martinique.
Questions about this recall
Why was it recalled?
The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130¿C. The correct sterilization temperature should be listed as 132¿C and/or 270¿F.
Which lots are affected?
Part Numbers 601-0007 and 601-0010, all lots
Where was it sold?
Worldwide distribution, including Nationwide (USA) and the countries of Canada, Austria, Belgium, Bulgaria, Switzerland, Germany, Denmark, France, Estonia, Spain, Finland, Iceland, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Luxembourg, Netherlands, Monaco, Poland, Romania, Serbia, Slovenia, Turkey, Jersey, and Martinique.
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.
More recalls from Ormco/Sybronendo
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ormco Damon Q2 Orthodontic Metal Bracket recalled by Ormco/Sybronendo | Ormco/Sybronendo | Labeling Errors | Nationwide |
| Device | CLASS II | SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022 recalled | Ormco/Sybronendo | Device Malfunction | 51 states |
| Device | CLASS II | SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022 recalled | Ormco/Sybronendo | Device Malfunction | 51 states |
| Device | CLASS II | Elements Obturation Unit (EOU) used recalled by Ormco/Sybronendo | Ormco/Sybronendo | Other | Nationwide |
| Device | CLASS II | Sealapex Xpress recalled by Ormco/Sybronendo | Ormco/Sybronendo | Packaging Defects | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |