Richard Wolf Reusable Rotary Blade Recalled for Weak Welds
Richard Wolf Medical Instruments Corp. is recalling two reusable rotary blades 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 used during surgical procedures where a mechanical failure (breakage) poses a risk of harm to the patient, but the source text does not report any injuries or illnesses.
Plain-English summary
Richard Wolf Medical Instruments Corp. is recalling two units of the reusable rotary blade/abrader, product number 899751514. This medical device is an attachment for air-powered equipment used during surgical procedures to cut hard tissue, bone, and soft tissue in general hospital and plastic surgery settings.
The recall was initiated because a weak weld in the reusable rotary blade 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 are from lot 4500166254 and were distributed in Washington. The source text does not specify the exact number of units distributed or the specific facilities affected.
The recalled product
- Product
- Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally 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.
- Manufacturer
- Richard Wolf Medical Instruments Corp.
- Hazard
- Affected units
- 2
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 4500166254.
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.
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