5 stories this morning, for surgeons and the people who support them.
- FDA puts its most serious recall classification on Boston Scientific's Infinion CX spinal cord stimulator leads after 1,081 serious injuries — FDA's early alert covers 1,079 unused Infinion CX lead kits (SC-2317-50 and SC-2317-70) that can take mechanical stress at the anchor site, producing high impedance or lead fracture. Boston Scientific reported 1,081 serious injuries and no deaths as of May 27, 2026, told customers on June 17 to stop use and distribution, and has already replaced the model with Infinion Pro for new implants; implanted leads are not affected. Source
- Shoulder Innovations clears the N-22 humeral head for metal-hypersensitive anatomic total shoulder and ships the same day — FDA 510(k) clearance announced September 10 for a titanium humeral head aimed at patients with metal hypersensitivity, with full commercial launch initiated immediately. It pairs with the N-22 glenosphere cleared in January 2026, giving the company a metal-sensitive option on both the anatomic and reverse sides. Source
- Shoulder Innovations takes exclusive US upper-extremity rights to ALM Ortho's patient-matched titanium implants — Announced September 9 and covered September 10, the exclusive US partnership gives Shoulder Innovations the upper-extremity applications of ALM Ortho's additively manufactured, patient-matched titanium implants for severe deformity and complex revision shoulders. Shoulder Innovations identifies candidates through its surgeon relationships and sales infrastructure; ALM Ortho designs, manufactures and delivers. Financial terms were not disclosed. Source
- restor3d launches MyFit, a patient-facing layer whose real payload is a 2,250-patient patient-specific implant registry — Launched September 8, MyFit sends hip and knee patients automated SMS updates through design and manufacturing and gives shoulder and foot-and-ankle patients a portal with an interactive 3D model of their own implant. It also enrolls patients into the restor3d Patient-Specific Registry, a prospective longitudinal registry of roughly 2,250 patients collecting patient-reported outcomes from baseline to five years. Source
- Biocomposites takes combination-antibiotic STIMULAN biofilm data to EBJIS-MSIS in Porto — An in-vitro poster at the 44th EBJIS annual meeting, held with MSIS in Porto September 17-19, reports that calcium sulfate beads loaded with combination antibiotic regimens eradicated early Staphylococcus aureus biofilm and significantly reduced mature biofilm on titanium, stainless steel and polyethylene. Biocomposites also hosts a September 17 symposium on infection practice across spine and arthroplasty. Source
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Narration is synthesized. Reporting and editorial judgement are ours, and every story above links to its source.