Reported Sep 4, 2024 · Completed
Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming,…
Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Corporation · 1941 Stryker Way · Portage, MI · 49002-9711
Is this the product you have?
- Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended
- to cut bone in the following mannerdrilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing
- for the following medical applicationsNeuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology
- and Endoscopic applications Ref8431-013-040DC
- Lot codes and dates
- GTIN07613327501155
- Lot Numbers
222480172226301722334017223480172234802723016027230950272312801723163017231790172320501723205027232050372322101723311017240040172400402724004037
- Amount recalled
- 5031 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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