FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: 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)
- Recall number
- Z-3206-2026
- Recalling firm
- Howmedica Osteonics Corp.
- 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)
- Status
- Open, Classified
- Initiated
- 2026-07-30
- Posted
- 2026-09-16
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process change control
- Action
- Firm began notifying customers on July 30, 2026, via FedEx 2-day air. Customers were instructed to quarantine and discontinue use of the affected product. Affected product should be returned to the firm.
- Quantity
- 12,156 US
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K051948","K052917","K243817","K252898"]
- PMA numbers
- not on file
- Product code
- NPJ
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28