SpineFrontier S-Lift Lock Shaft Inserter Recalled for Potential Breakage
SpineFrontier is recalling S-Lift Lock Shaft Inserters because the impact cap or pin may break during spinal surgery, potentially releasing fragments into the sterile field.
What this means for you
Illness, injury, or structural failure has been reported. 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 and involves a structural defect in a surgical instrument that could release fragments into a sterile field, posing a significant risk of injury during surgery.
Plain-English summary
SpineFrontier, Inc. is recalling 30 units of the S-Lift Lock Shaft Inserter (Part Number SI50001, Revisions A and B). This instrument is used in conjunction with the S-LIFT Intervertebral Body Fusion Device during spinal fusion surgery. The affected lots are 42613, 2478901R, 42615, and 7625701.
The recall was initiated because field use verification identified two possible breakage points when using the SI50001 Revision D Lock Shaft Inserter. The impact cap may shear off under high-impact force during insertion and removal, and the pin used to guide the Lock Shaft Inserter may also break. These breakages could result in instrument fragments entering the sterile field during surgery.
The affected devices were distributed nationwide in the United States, specifically in Oregon, Florida, Massachusetts, Texas, Colorado, Oklahoma, Illinois, and Missouri. Healthcare facilities and users of these devices should stop using the affected S-Lift Lock Shaft Inserters and contact SpineFrontier, Inc. for further instructions on the recall.
The recalled product
- Product
- SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter as
- Manufacturer
- SpineFrontier, Inc.
- Affected units
- 30
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 (6)
- S-Lift Lock Shaft Part number
- SI50001 Revisions: A
- B Lots: 42613
- 2478901R
- 42615
- 7625701
Distribution
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