CLASS II ONGOING Device recall · Reported 10 Jul 2024 · FDA Enforcement Report
Evolution¿ MP Femoral CS/CR Non-Porous MicroPort total recalled
MicroPort Orthopedics is recalling Evolution¿ MP Femoral CS/CR Non-Porous MicroPort total knee replacement implants are for. The recall was initiated on 3 May 2024 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-2244-2024
- FDA event ID
- 94729
- Recalling firm
- MicroPort Orthopedics, Arlington, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 May 2024
- FDA classified
- 1 Jul 2024
- Reported
- 10 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 3 May 2024 | Recall initiated by company | |
| 1 Jul 2024 | Classified by FDA | +59 days |
| 10 Jul 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
Where it was distributed
International distribution in the country of China. There is no field inventory in the United States for either lot.
Questions about this recall
Why was it recalled?
One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.
Which lots are affected?
UDI: Part EFSRN3PL: Primary DI Number M684EFSRN3PL1, Part EFSRN4PR: Primary DI Number M684EFSRN4PR1; lot Number's: MP1982097, MP1982170; Catalog Number(s): EFSRN3PL, EFSRN4PR
Where was it sold?
International distribution in the country of China. There is no field inventory in the United States for either lot.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from MicroPort Orthopedics
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MicroPort Hipturn Fem Head Trial Reusable recalled | MicroPort Orthopedics | Device Malfunction | 13 states |
| Device | CLASS II | Evolution Mp Femoral Component Cs/cr Porous Size 5 Right Primary recalled | MicroPort Orthopedics | Packaging Defects | TN |
| Device | CLASS II | Evolution MP Tibial Bases, Size 2+ Left recalled | MicroPort Orthopedics | Packaging Defects | TN |
| Device | CLASS II | Evolution MP Tibial Bases, Size 7 Left recalled by MicroPort Orthopedics | MicroPort Orthopedics | Packaging Defects | TN |
| Device | CLASS II | Profemur Plasma Z Classic Stem Size 7 Standard Short Neck recalled | MicroPort Orthopedics | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| 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 |