Arobella Medical, LLC: Medical Device Recall in 2012 - (Recall #: Z-0534-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product Usage: The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter.

Product Classification:

Class II

Date Initiated: November 5, 2012

Date Posted: December 26, 2012

Recall Number: Z-0534-2013

Event ID: 63808

Reason for Recall:

This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component of the AR1000 Quostic Wound Therapy System.

Status: Terminated

Product Quantity: 99

Code Information:

0001 and 0002

Distribution Pattern:

Worldwide distribution - US (nationwide) and the states of AL, CA, ID, IN, IA, MI, MN, MS, NJ, NM, OH, PA. SC, TX, UT, VA, WI. including the country of SAUDI ARABIA.

Voluntary or Mandated:

Voluntary: Firm initiated