SpineFrontier Recalls S-LIFT Extension Shims Due to Fit Variation
SpineFrontier, Inc. is recalling 67 S-LIFT Extension Shims because they may not fit down all retractor blades, potentially interfering with surgical procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (fit variation) without reporting any specific injuries, illnesses, or deaths. This aligns with the 'Moderate' severity criteria for low-risk contamination or functional issues without reported harm.
Plain-English summary
SpineFrontier, Inc. is recalling 67 units of S-LIFT Extension Shims. These medical devices are manufactured from grade 5 titanium and are designed to slide down retractor blades during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent it from interfering inside the surgical field.
The recall was initiated due to fit variation among all lots of the S-LIFT extension shims. The firm's investigation revealed that the extension shims may not fit down all corresponding retractor blades. This defect could potentially interfere with the intended use of the device during surgery.
The affected products were distributed nationwide, including in Florida, Texas, Oklahoma, Missouri, Illinois, Ohio, Virginia, Oregon, Colorado, Kansas, and Connecticut. Healthcare providers and facilities should stop using these specific shims and contact SpineFrontier, Inc. for instructions on return or replacement.
The recalled product
- Product
- S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shi
- Manufacturer
- SpineFrontier, Inc.
- Affected units
- 67
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 (8)
- Part Number/Lot Number: 11-50109 43092R
- 11-50109 46415
- 11-50109 CT12H013
- 11 -50109-1 46415-1
- 11-50110 43089
- 11-50110 43089R
- 11-50110 46416
- 11-50110-1 46416-1
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
Same hazard · functional defect
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereGE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
FDA (Devices) · 2025-05-07