The Recall Desk
HighFDA (Devices)·Z-0790-2016·Announced 2016-02-17

Richard Wolf Reusable Rotary Blade Recalled for Weak Welds

Richard Wolf Medical Instruments Corp. is recalling four reusable rotary blade/abrader units due to weak welds that may cause the product to break during surgical use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device used during surgery where a mechanical failure could cause harm, but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Richard Wolf Medical Instruments Corp. is recalling four units of the reusable rotary blade/abrader, product number 899751504. This medical device is an attachment for air-powered surgical instruments used to cut hard tissue, bone, and soft tissue in general hospital and plastic surgery settings.

The recall is being issued because of a weak weld in the reusable rotary blade/abrader. This defect may result in the inner part breaking at the distal or proximal end, which would make the product dysfunctional during a procedure.

The affected units are from lot 0207201502 and were distributed in Washington. No injuries or illnesses have been reported in connection with this recall. Users should stop using the affected product and contact the manufacturer for further instructions.

The recalled product

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.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Affected lot 0207201502.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Richard Wolf Medical Instruments Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Richard Wolf Medical Instruments Corp.

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