Olympus Thunderbeat II Shears recall due to distal tip detachment
Olympus Corporation of the Americas is recalling Olympus Thunderbeat II Shears (Model TB2-0520FC) because the distal tip component may detach during 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: FDA Class II recall of a surgical instrument with risk of component detachment during use that could harm patients. The source text does not report any illnesses or injuries, but the hazard (distal tip detachment in an active surgical device) presents a potential risk of harm.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Thunderbeat II Shears with Ultrasonic Mode, 5mm, 20cm (Model Number: TB2-0520FC) distributed internationally in Australia, Japan, Hong Kong, and Europe. The device has a potential for the distal tip component to detach during surgical use.
The detachment of the distal tip component during procedure could affect device function and patient safety. All lot numbers of the affected model are included in this recall. Affected units can be identified by the UDI-DI Number 04953170439995 and Model Number TB2-0520FC.
If you have this device, contact Olympus Corporation of the Americas for instructions on device replacement or return. Do not use the recalled device.
The recalled product
- Product
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 830
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)
- Model Number: TB2-0520FC. UDI-DI Number: 04953170439995. All Lot Numbers.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Olympus Corporation of the Americas 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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