Recall Z-0790-2016— Richard Wolf Medical Instruments Corp.

Name: FDA recall Z-0790-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-25

Class II · Terminated

Class II FDA medical device recall by Richard Wolf Medical Instruments Corp., initiated 2015-11-25, terminated 2017-08-21. It names one FDA 510(k) clearance: K984304. Product: 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: 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..

Recalling firm: Richard Wolf Medical Instruments Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-11-25
Terminated: 2017-08-21
Firm location: Vernon Hills, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K984304 — RIWO DRIVE GENERATORRichard Wolf Medical Instruments Corp.·cleared 1999-08-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.