Tornier Aequalis Pyrocarbon shoulder implants recalled for potential graphite exposure
Tornier recalls Aequalis Pyrocarbon shoulder implants (6,631 units) due to potential patient exposure to graphite substrate material. The units were distributed across multiple U.S. states.
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 medical device recall classified as a risk-of-harm product due to potential patient exposure to graphite substrate material from an implanted component. No illnesses or injuries have been reported.
Plain-English summary
Tornier S.A.S. is recalling the Aequalis Pyrocarbon Humeral Heads, shoulder implant components, due to potential patient exposure to the graphite substrate material. The affected devices are implanted surgical components used in shoulder procedures.
The recall affects 6,631 units distributed to patients in California, Colorado, Connecticut, Florida, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, Oregon, Pennsylvania, Texas, and Wisconsin. The recalled units include all lot codes of multiple catalog variations with diameters ranging from 39 to 54 mm.
Patients who have received these implants should consult with their implanting physician regarding this recall. Healthcare providers should contact Tornier S.A.S. for additional guidance on patient management and any necessary follow-up care.
The recalled product
- Product
- The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog
- Manufacturer
- Tornier S.A.S.
- Hazard
- graphite-exposure
- material-degradation
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)
- All Lot Codes
Distribution
Distributed in 15 states:
- CA
- CO
- CT
- FL
- KS
- LA
- MD
- MI
- MN
- MO
- NC
- OR
- PA
- TX
- WI
Related recalls
Same category
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighBoston Scientific CRE Pro Wireguided catheters recalled for packaging
FDA (Devices) · 2026-07-08
- ModerateMedline Convenience Kits recalled for defective Lidocaine Ampules
FDA (Devices) · 2026-07-08
- ModerateProvena Midline Catheters recalled due to deficient manufacturing practices
FDA (Devices) · 2026-07-08
- SevereThyroid FNA Pack-RX Surgical Kit Recalled for Bacterial Contamination
FDA (Devices) · 2026-07-08