SpineFrontier Recalls S-Lift Implant Guides Due to Over-insertion Risk
SpineFrontier, Inc. is recalling 19 units of S-Lift Implant Guides because using them without stops may allow over-insertion, potentially causing patient injury.
What this means for you
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 risk-of-harm medical device where injury has not yet been reported, fitting the 'High' severity criteria for potential patient injury without confirmed cases.
Plain-English summary
SpineFrontier, Inc. is recalling 19 units of S-Lift Implant Guides (also known as S-LIF), Compressor Part Number 11-50223, Lot Number 012064-001. These surgical guides are used by surgeons to place implants into tight spaces, such as the vertebral disc space, without the implant contacting surrounding bone or tissue.
The recall is due to a known risk that using the optional S-LIFT Implant Guides without stops may allow the guides, and possibly the implant, to move too far into the disc space. This over-insertion creates the potential for injury to the patient. The instructions for use for the S-Lift Implant Guides will be amended to add a warning advising care to prevent over-insertion.
The affected units were distributed nationwide in the United States, including the states of Massachusetts and Texas. Healthcare providers and consumers should stop using the affected S-Lift Implant Guides and contact SpineFrontier, Inc. for further instructions.
The recalled product
- Product
- S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case o
- Manufacturer
- SpineFrontier, Inc.
- Category
- Medical Device — Surgical Guides
- Affected units
- 19
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 (1)
- Lot Numbers: 012064-001
Distribution
Related recalls
Same manufacturer · SpineFrontier, Inc.
See all →- HighSpineFrontier Recalls A-CIFT SoloFuse Fixed Angle Driver Due to Binding Risk
FDA (Devices) · 2019-07-24
- ModerateSpineFrontier Recalls MISquito Pedicle Screw System Surgical Technique Document
FDA (Devices) · 2015-04-29
- HighSpineFrontier Recalls Inline Persuader Pedicle Screw System Due to Handle Crack
FDA (Devices) · 2015-01-21
- SevereSpineFrontier S-Lift Lock Shaft Inserter Recalled for Potential Breakage
FDA (Devices) · 2014-05-14
- ModerateSpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues
FDA (Devices) · 2014-01-22