The Recall Desk
HighFDA (Devices)·Z-0888-2024·Announced 2024-02-07

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.

What this means for you

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.
Hazard
  • material-oxidation
  • prosthetic-failure-risk

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.