SpineFrontier Invue Solid Driver Recalled Due to Broken Nipple
SpineFrontier, Inc. is recalling nine Invue Solid Drivers because the nipple broke off during use, potentially affecting spinal surgery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The source describes a mechanical failure (broken nipple) during a surgical procedure, which constitutes a significant injury risk or structural defect in a medical device context, aligning with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
SpineFrontier, Inc. is recalling nine units of the Invue Solid Driver, Tipped, AO (Part Number 11-70083). The recall involves specific lot numbers 011836-0001 and 011981-001. This medical device is used to retain screws when changing the axis of insertion during spinal intervertebral fixation.
The recall was initiated because the nipple of the tipped driver broke off while surgeons were attempting to insert a screw. This mechanical failure occurred during the intended use of the device.
The affected units were distributed in the District of Columbia and the states of Massachusetts and Oklahoma. Healthcare facilities and users should stop using these specific devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
- Manufacturer
- SpineFrontier, Inc.
- Affected units
- 9
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 (2)
- Lot Number: 011836-0001
- 011981-001
Distribution
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