Knee Replacement Implant Component Recalled Due to Material Oxidation Risk
The FDA is recalling SCORPIO U-DOME PATELLA knee replacement components because manufacturing used raw material over 5 years old that may have elevated oxidation levels affecting the implant's 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: FDA Class II medical implant recall involving material degradation risk with no reported injuries. The hazard—elevated oxidation in aged UHMWPE material—is theoretical with potential to impact implant properties, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The FDA is alerting healthcare providers to a recall of SCORPIO U-DOME PATELLA components for knee replacement (part number 73-3910), manufactured by Howmedica Osteonics Corp. The recall involves 143 units distributed in the United States and 290 units distributed internationally.
The recall affects units manufactured with specific lot numbers: 73JP, V17W, N2MY, PK0D, D3M3, LEAY, 4NTR, R5WA, JN8M, 084W, K6YE, 84A4, XREK, YNM1, LY5M, M1AT, and 4873.
The recall is due to the use of ultra-high-molecular-weight polyethylene (UHMWPE) raw material over 5 years of age in manufacturing. This material has the potential for elevated oxidation levels, which can impact the material properties of the implant.
The recalled product
- Product
- SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910
- 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 (17)
- GTIN: 07613327033915 Lot Numbers: 73JP
- V17W
- N2MY
- PK0D
- D3M3
- LEAY
- 4NTR
- R5WA
- JN8M
- 084W
- K6YE
- 84A4
- XREK
- YNM1
- LY5M
- M1AT
- 4873
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.
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