Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming,
Summary
The FDA issued a Class II for Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in by Stryker Corporation. Reason: Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than spe.
Details
Source
Device Recall
External ID
Z-2728-2024
Action Date
2024-09-04
Status
Completed
Category
device
Product Description
Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-013-040DC
Lot/Code Info: GTIN: 07613327501155 Lot Numbers: 22248017 22263017 22334017 22348017 22348027 23016027 23095027 23128017 23163017 23179017 23205017 23205027 23205037 23221017 23311017 24004017 24004027 24004037
Quantity Affected: 5031 units
Reason for Recall
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-24
Company
Portage, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 409 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Corporation have FDA actions?
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2728-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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