SpineFrontier T-Handle Strike Plate Separation Recall
SpineFrontier, Inc. is recalling 11 T-Handles because the strike plate loosened and separated during an operation.
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 involves a medical device that separated during an operation, representing a risk-of-harm product where specific injury has not yet been reported in the source text.
Plain-English summary
SpineFrontier, Inc. is recalling 11 units of T-Handle, Strike Plate, Push Connection (Part Number: SI50023 Rev A). The recalled T-handles are silicone handled instruments with a quick release end and an impactor cap designed to be struck with a mallet. These instruments are used to attach to and operate a wide range of instruments during the implantation of spinal intervertebral body fusion devices for skeletally mature patients.
The recall was initiated because the strike plate of a T-Handle loosened and separated from the T-Handle during an operation. The affected units are identified by Lot Numbers 1335201A and 1446101A.
The recalled products were distributed in the United States, including the states of Massachusetts, Nevada, and Texas. Healthcare facilities and users should stop using the affected T-handles and contact SpineFrontier, Inc. for further instructions.
The recalled product
- Product
- T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles…
- Manufacturer
- SpineFrontier, Inc.
- Hazard
- Affected units
- 11
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 Numbers: 1335201A
- 1446101A
Distribution
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