Z-0789-2016 Class II Terminated
FDA device recall Z-0789-2016 was initiated by Richard Wolf Medical Instruments Corp. on November 25, 2015 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated August 21, 2017). Affected quantity: Ten units.
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2016
- Initiation Date
- November 25, 2015
- Termination Date
- August 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Ten units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Distributed in Washington.
Code Information
Product numbers: 899751304, 899751305, 899751404, 899751405, 899751502, 899751503, 899751504, 899751514. Affected lots: 4500151676, 4500170289, 4500166254, 4500152568, 4500161974, 4500160509, 0207201501, 0207201502, 1109201501, 4500166254