Knee Replacement Component Recalled Due to Potential Material Degradation
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patellas manufactured with raw material over 5 years old, which may have elevated oxidation levels 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: FDA Class II recall of a load-bearing surgical implant with material degradation risk but no reported illnesses or injuries. Meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Howmedica Osteonics Corp. is recalling the SCORPIO Total Knee Concentric Dome Patella, Size #9 (Part Number 73-2910), used in total knee replacement surgery. This recall affects 16 units in the United States and 56 units distributed internationally. The affected lot numbers are A02W, NPPV, 75TX, and 6RLN.
The manufacturer identified that these units were manufactured with UHMWPE (ultra-high molecular weight polyethylene) raw material that was more than 5 years old. When UHMWPE material reaches this age, it can develop elevated levels of oxidation, which may affect its material properties. The products were distributed nationwide in the U.S. and internationally to multiple countries including Canada, Australia, Japan, Brazil, China, and others.
Patients who have had this knee implant placed should consult their orthopedic surgeon or healthcare provider to discuss the recall and determine whether any follow-up action is necessary.
The recalled product
- Product
- SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910
- 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 (4)
- GTIN: 07613327033854 Lot Numbers: A02W
- NPPV
- 75TX
- 6RLN
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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