Knee Replacement Implant Recalled Due to Material Oxidation Risk
Howmedica Osteonics recalled Scorpio Total Knee prosthetics with UHMWPE components produced from raw material over 5 years old, which may develop elevated oxidation and affect implant 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 for implant material degradation with potential but not yet reported adverse effects. The risk involves aged material that may develop oxidation affecting properties, but no clinical failures or injuries have been documented, placing it in the high-risk category for unmanifested product defects.
Plain-English summary
Howmedica Osteonics Corp. is recalling Scorpio Total Knee prosthetics, specifically the medialized dome patella size #7 (part number 73-0710). The recall involves 269 units distributed in the United States and 307 units distributed internationally to countries including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, and others.
The recalled units were manufactured using ultra-high-molecular-weight polyethylene (UHMWPE) raw material that was over 5 years of age at the time of production. Material that ages for extended periods can develop elevated levels of oxidation, which may negatively affect the material's mechanical properties and overall implant performance.
The affected lot numbers are: RLAR, 2P84, EW6V, 90AV, 4JHN, 65A3, 22MP, NNE7, Y373, 58LA, VXAL, 4201, A2AN, 5YP8, X0P9, 9A8T, 6LN7, WEL3, NDK3, 25WJ, T2JW, YVWT, 7DR0, and DMVL. The U.S. Food and Drug Administration classified this recall as Class II.
The recalled product
- Product
- SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710
- 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 (20)
- GTIN: 07613327050295 Lot Numbers: RLAR
- 2P84
- EW6V
- 90AV
- 4JHN
- 65A3
- 22MP
- NNE7
- Y373
- 58LA
- VXAL
- 4201
- A2AN
- 5YP8
- X0P9
- 9A8T
- 6LN7
- WEL3
- NDK3
- 25WJ
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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