Home / Recalls / Richard Wolf Medical Instruments Corp. / Z-0790-2016

Z-0790-2016 Class II Terminated

Recalled by Richard Wolf Medical Instruments Corp. — Vernon Hills, IL

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
four units

Product Description

Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded 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

Affected lot 0207201502.

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  • Z-0789-2016 Class II — Reuseable rotary blade/abrader, product number 899751305. The round burr is an (November 25, 2015)
  • Z-0791-2016 Class II — Reuseable rotary blade/abrader, product number 899751514. The oval burr frontal (November 25, 2015)
  • Z-1240-2015 Class II — The I-Cart is used to store, transport, and power video equipment used in medica (December 10, 2014)
  • Z-0037-2015 Class II — The Hulka Clip is a sterile packaged medical device that carries a two year expi (July 9, 2014)
  • Z-0145-2014 Class II — Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vapo (September 18, 2013)