Biomet Recalls Comprehensive VRS Inserter Shoulder Prosthesis Devices
Biomet is recalling 38 Comprehensive VRS Inserter shoulder prosthesis devices because the central screw drill may seize, potentially extending surgery time.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (surgical delay) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Biomet, Inc. is recalling 38 units of the Comprehensive VRS Inserter, a shoulder prosthesis device (Item No. 110019068). The affected lots are 814100, 570640, 728890, and 977300. The recall is classified as Class II by the FDA.
The recall is due to a defect where the central screw drill may seize inside the device. This malfunction may lead to an extension of surgery time as medical professionals attempt to find a replacement device.
The devices were distributed nationwide in the United States, specifically in California, Florida, Indiana, Kansas, Kentucky, Michigan, Ohio, and Texas. They were also distributed to the Netherlands. Consumers and healthcare providers should contact Biomet, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- 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
- Manufacturer
- Biomet, Inc.
- Affected units
- 38
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots 814100
- 570640
- 728890
- 977300
Distribution
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