STRATAFIX Spiral PDS Plus Surgical Mesh Recalled for Potential Barb Non-Engagement
ETHICON is recalling STRATAFIX Spiral PDS Plus surgical mesh devices (Lot 104DBB) due to potential barb non-engagement that could affect tissue fixation function.
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: FDA Class II device with potential functional failure (barb non-engagement) affecting the critical tissue fixation mechanism. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, resulting in High severity.
Plain-English summary
ETHICON, LLC is recalling the STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (Product Code SXPP2B400-11, Lot Number 104DBB). The recall affects 516 units distributed in the United States, Singapore, and Malaysia.
The recall is due to potential for barb non-engagement in the tissue control mechanism. The barbs are designed to engage and control tissue during surgical procedures. If barbs do not engage properly, the device may not perform its intended tissue fixation function.
Healthcare providers and facilities with access to the affected lot should verify their inventory and identify any devices matching the recalled product code and lot number. Patients with this device implanted should consult with their healthcare provider.
The recalled product
- Product
- STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.
- Manufacturer
- ETHICON, LLC
- Category
- Medical Device — Surgical Mesh
- Hazard
- barb-non-engagement
- tissue-fixation-failure
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)
- Product Code: SXPP2B400-11. GTIN: 10705031464568 (each)
- 30705031464562 (box of 12). Lot Number: 104DBB.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03
- HighPhilips Allura Imaging Systems Hard Drive Degradation Affects Functionality
FDA (Devices) · 2026-06-03