The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2194-2013·Announced 2013-09-18

Ormco Recalls Vector TAS 8mm Orthodontic Screws Due to Manufacturing Defect

Ormco is voluntarily recalling one lot of Vector TAS 8mm orthodontic screws because some were machined undersized, which may cause the screws to break during use.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect that poses a risk of harm (screw breakage requiring surgical removal), but the source text does not report any actual injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws. The recall affects Lot Number 112911, which includes the 8 MM Vector TAS Screw (Part Number 601-0021) and the Vector TAS Starter Kit (10 Patient) (Part Number 601-0010). A total of 4,786 units were distributed worldwide, including the United States, Canada, Australia, New Zealand, the EU, and other regions.

The recall is being issued because some screws from this lot were machined undersized at the top of the threads. This manufacturing defect may potentially cause a weakening of the screw. If the undersized product is used, it may result in the breakage of the screw during insertion or removal when torqued. In such cases, surgical removal of any remaining pieces may be required.

These screws are intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the movement of teeth. They are surgically placed in the bone of the upper or lower jaw arches and are used temporarily, removed after orthodontic treatment is completed. Consumers and healthcare providers should stop using the affected lot and contact the manufacturer for instructions on replacement or return.

The recalled product

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…
Manufacturer
Ormco/Sybronendo
Category
Medical Device — Orthodontic
Hazard
Affected units
4,786

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot Number 112911: 8 MM Vector TAS Screw
  • Part Number 601-0021 Lot Number 112911: Vector TAS Starter Kit (10 Patient)
  • Part Number 601-0010

Distribution

Distributed nationwide across the United States.

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