Food, drugs, devices › Ormco/Sybronendo
Device recall: Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a f
Ormco/Sybronendo (Glendora, CA) initiated this device recall on 12 Jul 2013; FDA lists 1 product record under event 66173, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 11 Sep 2014. Initiation: voluntary: firm initiated. Ormco/Sybronendo has 14 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ormco/Sybronendo, Glendora, CA.
Reason for recall
"Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. Use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces."
Distribution
"Worldwide Distribution - USA (nationwide) including the countries of Canada, Australia, New Zealand, EU and ROW consignees."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2194-2013 | Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after orthodontic treatment has been completed. It… | 4,786 | Class II | Terminated | 18 Sep 2013 |
Context
Other enforcement events for Ormco/Sybronendo
All 14 events for Ormco/Sybronendo
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. Use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA (nationwide) including the countries of Canada, Australia, New Zealand, EU and ROW consignees."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Sep 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.