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Recall Observatory FDA recall evidence

Device product

Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally 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.

Z-0791-2016

November 25, 2015

Class II

Product summary

Firm
Richard Wolf Medical Instruments Corp.
Event
Event 73091
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0791-2016

Official wording

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.

Code information: Affected lot 4500166254.

Distribution pattern: Distributed in Washington.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.