FDAFDA · Food and drugs·Recall number Z-0789-2016
Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
Published February 17, 2016 · Recall initiated: November 25, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Richard Wolf Medical Instruments Corp.
- Distributor
- Distributed in Washington.
- Lot
- Product numbers: 899751304, 899751305, 899751404, 899751405, 899751502, 899751503, 899751504, 899751514. Affected lots: 4500151676, 4500170289, 4500166254, 4500152568, 4500161974, 4500160509, 0207201501, 0207201502, 1109201501, 4500166254
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States