Stryker iBur 3.0mm Precision Match Head recall
Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping…
Why was Stryker iBur 3.0mm Precision Match Head 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: 07613327501193 Lot Numbers: 22228017 22257017 22269017 22276017 23085017 23095017 23157017 23157027 23179017 23179027 23198017 23213017 23221017 23299017 23345017 23345027
- Product
- Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping…
- Recalling firm
- Stryker Corporation
- Quantity
- 3673 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)