Stryker iBur 4.0mm Coarse Diamond Round recall
Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping…
Why was Stryker iBur 4.0mm Coarse Diamond Round recalled?
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 07613327501155 Lot Numbers: 22248017 22263017 22334017 22348017 22348027 23016027 23095027 23128017 23163017 23179017 23205017 23205027 23205037 23221017 23311017 24004017 24004027 24004037
- Product
- Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping…
- Recalling firm
- Stryker Corporation
- Quantity
- 5031 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, France, Hong Kong, India, Italy, Japan, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom.
- Recall date
- September 4, 2024
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)