Z-0534-2013Class II

Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of...

Name: Z-0534-2013 Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of...
Creator: Arobella Medical, LLC
Published: 2012-11-05
License: https://open.fda.gov/license/

Arobella Medical, LLC / initiated 2012-11-05 / Terminated / root cause: manufacturing process

FDA source

Arobella Medical, LLC began a recall of Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an... on 2012-11-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0534-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-05
Posted: 2012-12-17
Terminated: 2015-03-04
Recalling firm: Arobella Medical, LLC
Product: 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 code: LFL Instrument, Ultrasonic Surgical
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Arobella Medical sent an " Urgent: Medical Device Recall" letter dated November 2, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory, quarantine and return any product subject to the recall. If the affected product have been further distributed, customers were advised to notify their customers of the product recall. For questions call 952-288-2810.
Quantity in commerce: 99
Distribution: 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.
Product codes and lots: 0001 and 0002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0534-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0534-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-17

Product code LFL

K062544UnclassifiedAr1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC / cleared 2007-01-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)