Recall Z-0534-2013 ยท LFL Instrument, Ultrasonic Surgical
Arobella Medical, LLC
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 tissu
| Date | Dec 17, 2012 (initiated Nov 5, 2012) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062544 | AR1000 ULTRASONIC WOUND THERAPY SYSTEM Arobella Medical, LLC, Jan 3, 2007 |