CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report
Scorpio Recessed Metal Backed Patella 3045 recalled
Howmedica Osteonics is recalling Scorpio Recessed Metal Backed Patella 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic, 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-3203-2026
- 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
- Foreign Material
- 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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 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?
3045-0026 No UDI Lots 12WAHA 12WAHB HOHE HOVX 3045-0028 No UDI Lots 13VAW 13VAWA 3045-0030 No UDI Lots BIYIE HNZY 3045-0032 No UDI Lots BIYIH HOYK
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 99558This product is part of a recall event; the main page for the event is Scorpio C-dome Patella 73-2710 73-2910 Scorpio U-dome recalled.
More 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 | 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 |
| Device | CLASS II | Duracon XL Angled Tib Ins C-m064-1-300 Self-pressurizing 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 | 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 |
| Device | CLASS II | Duracon XL Angled Tib Ins C-m064-1-300 Self-pressurizing recalled | Howmedica Osteonics | Other | Nationwide |