Knee replacement component recalled due to potential material oxidation
Howmedica Osteonics recalls SCORPIO U-DOME PATELLA knee components. Older UHMWPE raw material may have elevated oxidation, potentially affecting material properties.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves potential material property degradation in a prosthetic component due to oxidation, which represents a risk of harm where injury has not yet been reported, warranting a High (Score 3) severity rating.
Plain-English summary
Howmedica Osteonics Corp. is recalling SCORPIO U-DOME PATELLA knee replacement components (Part Number 73-3710). A total of 118 units were distributed in the United States, with an additional 212 units distributed to international markets.
The recall was initiated because UHMWPE raw material older than 5 years may have elevated oxidation levels. Oxidation within UHMWPE can compromise its material properties, which are essential for proper function of the knee prosthetic component.
The affected lot numbers are: RNT5, 3YNP, PEA1, NNA5, 5A2R, 98AH, T1JH, 8D72, E0VH, 3PA0, 05L4, and R608. The product was distributed nationwide within the United States and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, and other countries.
Patients and healthcare providers should contact Howmedica Osteonics Corp. or the FDA with questions regarding this recall or if they have concerns about affected implants.
The recalled product
- Product
- SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
- Manufacturer
- Howmedica Osteonics Corp.
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 (12)
- GTIN: 07613327033908 Lot Numbers: RNT5
- 3YNP
- PEA1
- NNA5
- 5A2R
- 98AH
- T1JH
- 8D72
- E0VH
- 3PA0
- 05L4
- R608
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 58 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 58 products in this recall →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 Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
Same hazard · oxidation
See all →- HighIcosapent ethyl capsules recalled as subpotent after capsule contents leaked
FDA (Drugs) · 2026-01-28
- ModerateIcosapent Ethyl Capsules Recalled for Failed Tablet Specifications
FDA (Drugs) · 2025-06-18
- ModerateExactech Shoulder Implant Components Recalled for Nonconforming Oxygen Barrier Packaging
FDA (Devices) · 2024-04-10
- HighKnee Replacement Tibial Inserts Recalled Due to Material Oxidation Risk
FDA (Devices) · 2024-02-07
- HighKnee implant component recalled due to potential material oxidation
FDA (Devices) · 2024-02-07
Similar recalls
- HighHowmedica Recalls Scorpio Receded Metal Backed Patella Implants
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Scorpio Patella Implants Due to Polyethylene Wear Risk
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
- SevereHowmedica Recalls Trident Polyethylene Knee Inserts Due to Material Aging
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23