Spine Wave Recalls Lumbar Intervertebral Fusion Implants Due to Material Error
Spine Wave, Inc. is recalling 17 units of the StaXx IB Convex Expandable Implant because the superior endplate was manufactured from a different polymer than specified.
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 structural material deviation in a medical device where no injuries have been reported, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Spine Wave, Inc. is recalling 17 units of the StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), an intervertebral fusion device indicated for lumbar procedures in skeletally mature patients. The recall was initiated because a component, the superior endplate, was manufactured from a different polymer than specified in the product design.
The affected units, identified by Lot Numbers 272L08 and 272L09, were distributed in the states of Florida and Oregon. The source text does not report any illnesses or injuries associated with this recall.
Healthcare providers and patients who have received this device should contact Spine Wave, Inc. for further instructions regarding the recall and potential replacement or removal of the implant.
The recalled product
- Product
- StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.
- Manufacturer
- Spine Wave, Inc.
- Hazard
- Affected units
- 17
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: 272L08 and 272L09
Distribution
Related recalls
Same manufacturer · Spine Wave, Inc.
See all →- ModerateSpine Wave Access Kit Recalled for Mislabeled Probe Dimensions
FDA (Devices) · 2015-07-08
Same hazard · material defect
See all →- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- LowParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- HighNexxZr dental zirconia discs may have reduced or missing dentin layer
FDA (Devices) · 2026-06-17
Similar recalls
- HighDePuy Spine Recalls Concorde Lift Spinal Fusion Implants
FDA (Devices) · 2019-05-08
- HighIntervertebral fusion device recalled for packaging non-conformity issue
FDA (Devices) · 2023-08-30
- HighIntervertebral Fusion Device Recalled for Potential Packaging Defect
FDA (Devices) · 2023-08-30
- ModerateMedicrea IMPIX ALIF Lumbar Fusion Devices Recalled for Packaging Defect
FDA (Devices) · 2023-08-30
- HighMedtronic Catalyft LS spinal implant recalled for out-of-specification device dimensions
FDA (Devices) · 2023-07-19
- HighMedtronic spinal implant recall due to out-of-specification device dimensions
FDA (Devices) · 2023-07-19