Stryker Corporation 2024-09-04 Health serious FDA
Health · FDA · Recall #FDA-Z-2727-2024
Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the… Recall
Issued September 4, 2024 · Stryker Corporation
In September 2024, Stryker Corporation recalled the Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Stryker Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Stryker Corporation
- Category
- Health
- Recall date
- September 4, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, France, Hong Kong, India, Italy, Japan, Japan, Netherlands, S
- Recall number
- FDA-Z-2727-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Stryker Corporation has 15 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.