Reported Sep 4, 2024 · Completed
Stryker iBur 3.0mm Precision Match Head, 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 3.0mm Precision Match Head, 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 Ref8431-107-530
- Lot codes and dates
- GTIN07613327501193
- Lot Numbers
22228017222570172226901722276017230850172309501723157017231570272317901723179027231980172321301723221017232990172334501723345027
- Amount recalled
- 3673 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Stryker Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.