The Recall Desk
HighFDA (Devices)·Z-0789-2016·Announced 2016-02-17

Richard Wolf Reusable Rotary Blade Recall Due to Weak Welds

Richard Wolf Medical Instruments Corp. is recalling ten 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 medical device with a structural defect that could cause the product to break during surgery. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Richard Wolf Medical Instruments Corp. is recalling ten units of the reusable rotary blade/abrader, product number 899751305. This medical device is an attachment for air-powered tools used in surgical procedures to cut hard tissue, bone, and soft tissue in general hospital and plastic surgery settings.

The recall is being issued because a weak weld in the reusable rotary blade/abrader may result in the inner part breaking at the distal or proximal end. This defect can make the product dysfunctional during use. The affected units were distributed in Washington.

Hospitals and surgical facilities should stop using the affected product immediately. Users should contact Richard Wolf Medical Instruments Corp. for instructions on how to return the product or obtain a replacement.

The recalled product

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.
Manufacturer
Richard Wolf Medical Instruments Corp.
Category
Medical Device — Surgical Instrument
Hazard

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 (16)

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

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 →

Related recalls

Same manufacturer · Richard Wolf Medical Instruments Corp.

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Same hazard · structural defect

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