Z-2722-2024 Class II
FDA device recall Z-2722-2024 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: 1612 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
- 1612 units
Product Description
Stryker iBur 3.0mm Precision 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: 8431-009-030
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: 07613327501247 Lot Numbers: 22224017 22234017 22234027 22250017 22293017 22299017 23157017 23179017 23179027 23299017