CLASS II ONGOING Device recall · Reported 17 Apr 2024 · FDA Enforcement Report
Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V Eli recalled
Synovo Production is recalling Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V Eli, TiN Ceramic W/ Plasma Spray, Sterileeo, distributed nationwide in the US. The recall was initiated on 30 May 2023 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-1498-2024
- FDA event ID
- 94278
- Recalling firm
- Synovo Production, Fullerton, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 May 2023
- FDA classified
- 8 Apr 2024
- Reported
- 17 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 30 May 2023 | Recall initiated by company | |
| 8 Apr 2024 | Classified by FDA | +314 days |
| 17 Apr 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
Medical device components were marketed without FDA clearance
Product as listed by the FDA
Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052
Where it was distributed
US Nationwide distribution in the state of WA.
Questions about this recall
Why was it recalled?
Medical device components were marketed without FDA clearance
Which lots are affected?
UDI/REF Number: 00814193025708/01-03-0042; 00814193025678/01-03-0044; 00814193025692/01-03-0045; 00814193025685/01-03-0047; 00814193025654/01-03-0049; 00814193025661/01-03-0051; 00814193025753/01-03-0052; REF Number/Lot Number: 01-03-0044 01030044K2NN656, 01-03-0044 01030044K3NN736, 01-03-0045 01030045LNN657, 01-03-0045 01030045MNN670, 01-03-0045 01030045N1NN694, 01-03-0045 01030045NNN694, 01-03-0045 01030045QNN733, 01-03-0045 01030045RNN742, 01-03-0047 01030047LNN657, 01-03-0047 01030047L4NN662, 01-03-0047 01030047MNN674, 01-03-0047 01030047N1NN689, 01-03-0047 01030047NNN689, 01-03-0047 01030047QNN733, 01-03-0049 01030049MNN662, 01-03-0049 01030049M8NN670, 01-03-0049 01030049QNN687, 01-03-0049 01030049R1NN724, 01-03-0049 01030049RNN725, 01-03-0049 01030049UNN732, 01-03-0049 01030049UNN733, 01-03-0049 01030049NNN736, 01-03-0051 01030051K3NN658, 01-03-0051 01030051K4NN666, 01-03-0051 01030051K4NN667, 01-03-0051 01030051KNN673, 01-03-0051 01030051LNN685, 01-03-0051 01030051M1NN694, 01-03-0051 01030051M3NN694, 01-03-0051 01030051MNN694, 01-03-0051 01030051M4NN697, 01-03-0051 01030051NNN731, 01-03-0051 01030051N1NN732, 01-03-0051 01030051N1NN733, 01-03-0051 01030051Q1NN739, 01-03-0051 01030051QNN742, 01-03-0052 01030052JNN663, 01-03-0052 01030052KNN669, 01-03-0052 01030052GNN685, 01-03-0052 01030052LNN694, 01-03-0052 01030052L1NN694, 01-03-0052 01030052L2NN694, 01-03-0052 01030052L3NN694, 01-03-0052 01030052MNN733,
Where was it sold?
US Nationwide distribution in the state of WA.
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.
Other products in this recall event
2 other products · FDA event 94278| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Acetabular Fixation Cup, (xx)MM, 5 Hole recalled by Synovo Production | Synovo Production | Other | Nationwide | |
| CLASS II | Acetabular Bearing (xx)MM I.D X (xx) O.D recalled by Synovo Production | Synovo Production | Other | Nationwide |
More recalls from Synovo Production
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Acetabular Bearing (xx)MM I.D X (xx) O.D recalled by Synovo Production | Synovo Production | Other | Nationwide |
| Device | CLASS II | Acetabular Fixation Cup, (xx)MM, 5 Hole recalled by Synovo Production | Synovo Production | 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 | Device Malfunction | 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) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |