Knee replacement implant recalled for material oxidation risk
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement components due to potential oxidation of the UHMWPE material in units manufactured with raw material over 5 years of age.
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 a risk-of-harm medical device (orthopedic implant) where injury has not yet been reported. The FDA Class II recall addresses theoretical material oxidation in UHMWPE components without reported illnesses or injuries.
Plain-English summary
Howmedica Osteonics Corp. is recalling 70 units of the SCORPIO RECESSED PATELLA knee replacement (Part Number 3044-0032) distributed nationwide in the United States and internationally.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can impact its material properties.
Patients with implanted devices from the affected lot numbers (6LR4, R14V, N882) should consult with their orthopedic surgeon or healthcare provider regarding potential risks and whether any action is needed.
The recalled product
- Product
- SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 70
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: 07613327033823 Lot Numbers: 6LR4
- R14V
- N882
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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