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
Reported: June 17, 2020 Initiated: May 11, 2020 #Z-2300-2020
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.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 38
- Distribution
- US Nationwide Distribution in the states of CA, FL, IN, KS, KY, MI, OH, and TX. Foreign distribution to Netherlands.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Biomet, Inc.. Units affected: 38.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2020. Severity: Moderate. Recall number: Z-2300-2020.
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