Z-2300-2020 Class II Terminated
FDA device recall Z-2300-2020 was initiated by Biomet, Inc. on May 11, 2020 and is designated Class II. Reason for recall: The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device. The recall status is terminated (terminated November 4, 2020). Affected quantity: 38.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- May 11, 2020
- Termination Date
- November 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38
Product Description
Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300
Reason for Recall
The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.
Distribution Pattern
US Nationwide Distribution in the states of CA, FL, IN, KS, KY, MI, OH, and TX. Foreign distribution to Netherlands.
Code Information
Lots 814100, 570640, 728890, 977300