Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: structural-defect
product-breakage

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 →

Same manufacturer · Richard Wolf Medical Instruments Corp.

See all →

Moderate
Richard Wolf Recalls E-Line Cutting Electrode Due to Incorrect Product Packaging
FDA (Devices) · 2019-07-17
High
Richard Wolf Conical Portio Adapter Recall Due to Weld Defect
FDA (Devices) · 2016-08-31
Moderate
Richard Wolf Vesa 75/100 Adaptation Recalled for Missing Rivets
FDA (Devices) · 2016-03-23
High
Richard Wolf Reusable Rotary Blade Recalled for Weak Welds
FDA (Devices) · 2016-02-17
High
Richard Wolf Reusable Rotary Blade Recalled for Weak Welds
FDA (Devices) · 2016-02-17

Same hazard · structural defect