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Recall Observatory FDA recall evidence

Device product

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.

Z-0789-2016

November 25, 2015

Class II

Product summary

Firm
Richard Wolf Medical Instruments Corp.
Event
Event 73091
Status
Terminated
Classification
Class II
Quantity
Ten units
Official record key
device-enforcement:Z-0789-2016

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: Product numbers: 899751304, 899751305, 899751404, 899751405, 899751502, 899751503, 899751504, 899751514. Affected lots: 4500151676, 4500170289, 4500166254, 4500152568, 4500161974, 4500160509, 0207201501, 0207201502, 1109201501, 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.