Z-2731-2024 Class II
FDA device recall Z-2731-2024 was initiated by Stryker Corporation on July 24, 2024 and is designated Class II. 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 tis… Affected quantity: 3673 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2024
- Initiation Date
- July 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3673 units
Product Description
Stryker iBur 3.0mm Precision Match Head, 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: 8431-107-530
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 Pattern
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.
Code Information
GTIN: 07613327501193 Lot Numbers: 22228017 22257017 22269017 22276017 23085017 23095017 23157017 23157027 23179017 23179027 23198017 23213017 23221017 23299017 23345017 23345027