CLASS II Device recall · Reported 17 Feb 2016 · FDA Enforcement Report

Reuseable rotary blade/abrader, product number recalled

Richard Wolf Medical Instruments is recalling Reuseable rotary blade/abrader, product number 899751305, distributed in Washington. The recall was initiated on 25 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct numbers: 899751304, 899751305, 899751404, 899751405, 899751502, 899751503, 899751504, 899751514. Affected lots: 4500151676, 4500170289, 4500166254, 4500152568, 4500161974, 4500160509, 0207201501, 0207201502, 1109201501, 4500166254

Quantity recalledTen units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0789-2016
FDA event ID: 73091
Recalling firm: Richard Wolf Medical Instruments, Vernon Hills, IL
Classification: Class II
Status: Terminated
Recall initiated: 25 Nov 2015
FDA classified: 9 Feb 2016
Reported: 17 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

25 Nov 2015	Recall initiated by company
9 Feb 2016	Classified by FDA	+76 days
17 Feb 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Distributed in Washington.

Washington

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

Distributed in Washington.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 73091

Reported	Class	Recall	Company	Reason	Where
17 Feb 2016	CLASS II	Reuseable rotary blade/abrader, product number recalled	Richard Wolf Medical Instruments	Device Malfunction	WA
17 Feb 2016	CLASS II	Reuseable rotary blade/abrader, product number recalled	Richard Wolf Medical Instruments	Device Malfunction	WA

More recalls from Richard Wolf Medical Instruments

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17 Feb 2016Device	CLASS II	Reuseable rotary blade/abrader, product number recalled	Richard Wolf Medical Instruments	Device Malfunction	WA

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