CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report
Scorpio C-dome Patella 73-2710 73-2910 Scorpio U-dome recalled
Howmedica Osteonics is recalling Scorpio C-dome Patella 73-2710 73-2910 Scorpio U-dome Patella 73-3110 73-3508 73-3708, distributed nationwide in the US. The recall was initiated on 30 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3206-2026
- FDA event ID
- 99558
- Recalling firm
- Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jul 2026
- FDA classified
- 16 Sep 2026
- Reported
- 23 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 30 Jul 2026 | Recall initiated by company | |
| 16 Sep 2026 | Classified by FDA | +48 days |
| 23 Sep 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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)
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
Questions about this recall
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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 99558More recalls from Howmedica Osteonics
All 244| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |
| Device | CLASS II | Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio + Mobile Bearing Pcs 78-5-0910 System One Bipolar recalled | Howmedica Osteonics | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,109| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |
| Device | CLASS II | Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio + Mobile Bearing Pcs 78-5-0910 System One Bipolar recalled | Howmedica Osteonics | Other | Nationwide |