CLASS II ONGOING Device recall · Reported 25 Dec 2024 · FDA Enforcement Report
Evolution Mp Femoral Component Cs/cr Porous Size 5 Right Primary recalled
MicroPort Orthopedics is recalling Evolution Mp Femoral Component Cs/cr Porous Size 5 Right Primary. The recall was initiated on 29 Oct 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-0699-2025
- FDA event ID
- 95672
- Recalling firm
- MicroPort Orthopedics, Arlington, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Oct 2024
- FDA classified
- 18 Dec 2024
- Reported
- 25 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 29 Oct 2024 | Recall initiated by company | |
| 18 Dec 2024 | Classified by FDA | +50 days |
| 25 Dec 2024 | 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
Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect 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 COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component
Where it was distributed
OUS: CN, GR, ES, ZA, FR, JP, IT
Questions about this recall
Is Evolution Mp Femoral Component Cs/cr Porous Size 5 Right Primary recalled?
Yes. MicroPort Orthopedics recalled Evolution Mp Femoral Component Cs/cr Porous Size 5 Right Primary on 29 Oct 2024. The recall is Class II and its status is Ongoing. Recall number Z-0699-2025.
Why was it recalled?
Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
Which lots are affected?
REF/UDI-DI/Lot/Expiration: EFSRP5PR/M684EFSRP5PR1/2007116/2032-05-06. EFSRN6PL/M684EFSRN6PL1/MP2002559/2032-05-06.
Where was it sold?
OUS: CN, GR, ES, ZA, FR, JP, IT
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 21 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 CS/CR Non-Porous Non-porous recalled | MicroPort Orthopedics | Packaging Defects | Nationwide |
| Device | CLASS II | Evolution MP Tibial Bases, Size 2+ Left recalled | MicroPort Orthopedics | Packaging Defects | Nationwide |
| Device | CLASS II | Evolution MP Tibial Bases, Size 7 Left recalled by MicroPort Orthopedics | MicroPort Orthopedics | Packaging Defects | Nationwide |
| Device | CLASS II | Profemur Plasma Z Classic Stem Size 7 Standard Short Neck recalled | MicroPort Orthopedics | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |