Medtronic ENT Surgical Cutting Bur Distributed Past Expiration Date
Medtronic Xomed recalled an ENT Ultra Round Steel Cutting Bur (Model REF 31313069) because it was distributed past its expiration date. This device was distributed internationally, including to Canada.
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: FDA Class II medical device used in surgical procedures. Distribution of surgical instruments past their expiration date represents a risk-of-harm situation, as expired devices may have compromised integrity or sterility that could affect patient safety during use.
Plain-English summary
Medtronic Xomed, Inc. recalled the ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 (Lot 0219937928, UDI/DI 0076300004142) because the product was distributed past its expiration date.
The recalled device was distributed internationally, including to Canada. Healthcare facilities and practitioners who received this product should verify the expiration date and take appropriate action with any units that exceed the expiration date.
Healthcare facilities that have received the affected product should contact Medtronic Xomed with any questions or concerns regarding the recall.
The recalled product
- Product
- Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
- Manufacturer
- Medtronic Xomed, Inc.
- Hazard
- Affected units
- 1
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 (2)
- UDI/DI 0076300004142
- Lot Number 0219937928
Distribution
Distribution scope not specified by the agency.
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