The Recall Desk
HighFDA (Devices)·Z-2797-2015·Announced 2015-09-30

Bien Air Dental Contra-Angles Recalled for Potential Tool Loosening

Bien Air Dental SA is recalling specific EVO 15 contra-angles because the dental tool may loosen and be swallowed.

What this means for you

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 risk-of-harm product (swallowing a dental tool) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Bien Air Dental SA is recalling 112 units of Contra-Angles CA1:1L EVO 15 in the United States. The affected products are identified by catalog numbers 1600939-001 and 1600938-001. The recall covers serial numbers 15B0001 through 15F0011 for catalog number 1600939-001 and serial numbers 15B0007 through 15F0027 for catalog number 1600938-001.

The recall is being conducted because the dental tool may loosen, which could lead to the potential swallowing of the tool. These devices are used for general dentistry procedures. The products were distributed worldwide, with U.S. distribution limited to one distributor in Florida.

Dental professionals and consumers should stop using the affected contra-angles immediately. Users should check their inventory for the specific catalog and serial numbers listed in this notice to determine if they possess the recalled items.

The recalled product

Product
Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
Manufacturer
Bien Air Dental SA
Category
Medical Device — Dental Instrument
Hazard
Affected units
112

Distribution

Distributed in 1 state:

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