Howmedica Recalls Scorpio Patella Implants Due to Polyethylene Wear Risk
Howmedica is recalling specific Scorpio patella implants because aged polyethylene material may cause excessive wear, leading to device failure and potential revision surgery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical implant that can lead to device fracture and the need for revision surgery, meeting the criteria for a Severe rating.
Plain-English summary
Howmedica Osteonics Corp. is recalling specific lots of SCORPIO C-DOME and U-DOME patella orthopaedic implant components. The affected devices were manufactured using Ultra High Molecular Weight Polyethylene (UHMWPE) raw material that was aged in excess of five years. The recall covers 12,156 units distributed in the United States and internationally, including Canada, LATAM, Europe, Asia Pacific, and South Africa.
The recall is due to the potential for elevated levels of oxidation in the aged polyethylene material. This oxidation may result in increased wear, which can lead to hazards such as excessive wear debris, material fragments, a fractured device, or a disassociated device. Potential harms associated with these failures include the need for revision surgery, pain, and inflammation.
Patients who have received these specific implant components should contact their orthopaedic surgeon to discuss the recall and determine if any follow-up care or monitoring is necessary. Healthcare providers should verify the specific lot numbers and UDI-DI codes against the recall list to identify affected patients.
The recalled product
- Product
- SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 12,156
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Howmedica Osteonics Corp.
See all →- ModerateHowmedica Recalls Triathlon Hinge Femoral Prep Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls Triathlon Universal Baseplate Finishing Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Triathlon Instrument Trays Recalled for Sterilization Dry Time Issue
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls TS Femoral Prep Trays Due to Sterilization Instructions
FDA (Devices) · 2026-10-21
- HighHowmedica Recalls Scorpio Receded Metal Backed Patella Implants
FDA (Devices) · 2026-09-23
Same hazard · device fracture
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- SevereHowmedica Recalls Aged Orthopaedic Implant Components Due to Wear Risk
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
Similar recalls
- HighHowmedica Recalls Scorpio Receded Metal Backed Patella Implants
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implants Due to Polyethylene Material Aging
FDA (Devices) · 2026-09-23
- HighFDA Recalls SCORPIO U-DOME Knee Implants for Potential Material Oxidation
FDA (Devices) · 2024-02-07
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
- HighKnee replacement patella component recalled due to material oxidation risk
FDA (Devices) · 2024-02-07