FDA Medical devices recall ·
SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110… recall
- Recall number
- Z-3206-2026
- Date
- (initiated July 30, 2026)
- Company / brand
- Howmedica Osteonics Corp.
325 Corporate Dr, Mahwah, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12,156 US
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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 (polyethylene)
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
73-2710 UDI-DI 07613327033847 Lot NPPV 73-2910 UDI-DI 07613327033854 Lot 14AGFD 73-3110 UDI-DI 07613327033861 Lots 1L45 4JM5 7EL5 AME3 MK74 NTV7 PYHM RE7J VEWJ 73-3508 UDI-DI 07613327033885 Lots HMM5 NLRE 73-3708 UDI-DI 07613327033892 Lots 3467 3D8D PMRHX1 T6YJ T9ME VWDA YAM7 73-3710 UDI-DI 07613327033908 Lots 3W25 DLYP 73-3910 UDI-DI 07613327033915 Lots 14NEYA 1XED 9Y3T D1M9 D2YP EX8T KRT3 KRT3X1 T325 V8X8 X6YE
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3206-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.