Z-2797-2015 Class II Terminated

Recalled by Bien Air Dental SA — Biel/bienne, N/A

Recall Details

Product Type
Devices
Report Date
September 30, 2015
Initiation Date
August 27, 2015
Termination Date
March 31, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
112 (U.S.)

Product Description

Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

Reason for Recall

Possible loosening of the dental tool, which may lead to potential swallowing of the tool.

Distribution Pattern

Worldwide Distribution - US distribution to one distributor in FL.

Code Information

Catalog numbers: 1600939-001 and 1600938-001 Serial numbers concerned: - Ref: 1600939-001: Serial numbers included in the following range: 15B0001 up to 15F0011 - Ref: 1600938-001: Serial numbers included in the following range: 15B0007 up to 15F0027