Knee Replacement Implant Recalled Due to Potential Material Degradation
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material may develop elevated oxidation levels that could affect the implant's performance.
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 FDA Class II recall involves a risk-of-harm medical implant with no reported illnesses or injuries. The hazard—potential oxidation in aged UHMWPE material affecting structural properties—is theoretical. Per the severity rubric, this meets the High (3) criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling the SCORPIO RECESSED PATELLA knee replacement implant (Part Number: 3044-0030). A total of 77 units were distributed in the United States and 2 units were distributed internationally.
The recall was issued because UHMWPE (ultra-high-molecular-weight polyethylene) raw material used in these implants that is over 5 years old can develop elevated levels of oxidation. Oxidation can affect the material's structural properties and potentially impact implant performance.
The affected lot numbers are PD99, 6AHH, and RY3J. International distribution includes Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
Patients who have received this implant should contact their orthopedic surgeon or healthcare provider to determine if they are affected and discuss any appropriate clinical follow-up.
The recalled product
- Product
- SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030
- 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 (3)
- GTIN: 07613327033809 Lot Numbers: PD99
- 6AHH
- RY3J
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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