Brand Name: Vector TAS 8mm Screw — Class II medical device recall Z-2194-2013
Terminated recall by Ormco/Sybronendo, reported 2013-09-18, distributed nationwide. Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot w
| Recall number | Z-2194-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ormco/Sybronendo, Glendora, CA, United States |
| Recall initiated | 2013-07-12 |
| Classified | 2013-09-12 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2014-09-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, NZ |
| Quantity | 4,786 |
| Reason classes | device malfunction |
| Lot numbers | 112911 |
| Model numbers | 601-0010, 601-0021 |
Product
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 is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2194-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.