Scorpio 72-16-1112Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K011643, K243817); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 30, 2026Open, Classified

   Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

   Z-3197-2026 · Root cause: Process change control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011643, K243817. One submission often covers many models, so check the product and lot details in each record.

• Z-3206-2026 · Jul 30, 2026 · Open, Classified
  SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyet
• Z-0884-2024 · Dec 1, 2023 · Open, Classified
  Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
• Z-0885-2024 · Dec 1, 2023 · Open, Classified
  Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910