Acetabular Fixation Cup (Synovo) – FDA Approval Missing (2023)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566
Brand
Synovo Production
Lot Codes / Batch Numbers
UDI/REF Number:00814193025807/01-01-0554, 00814193025814/01-01-0556, 00814193025821/01-01-0558, 00814193025838/01-01-0560, 00814193025845/01-01-0562, 00814193025852/01-01-0564, 00814193025869/01-01-0566, REF Number/Lot Number: 01-01-0562 01010562H1NN732, 01-01-0562 01010562HNN733, 01-01-0562 01010562J1NN745, 01-01-0564 01010564CNN656, 01-01-0564 01010564C3NN658, 01-01-0564 01010564CNN659, 01-01-0564 01010564DNN671, 01-01-0564 01010564D1NN681, 01-01-0564 01010564ENN697, 01-01-0564 01010564E2NN698, 01-01-0564 01010564FNN733, 01-01-0564 01010564G1NN744, 01-01-0564 01010564GNN746, 01-01-0566 01010566CNN663, 01-01-0566 01010566BNN670, 01-01-0566 01010566BNN671, 01-01-0566 01010566BNN688, 01-01-0566 01010566BNN689, 01-01-0566 01010566DNN699, 01-01-0566 01010556E1NN726, 01-01-0566 01010556E1NN727
Products Sold
UDI/REF Number:00814193025807/01-01-0554, 00814193025814/01-01-0556, 00814193025821/01-01-0558, 00814193025838/01-01-0560, 00814193025845/01-01-0562, 00814193025852/01-01-0564, 00814193025869/01-01-0566, REF Number/Lot Number: 01-01-0562 01010562H1NN732, 01-01-0562 01010562HNN733, 01-01-0562 01010562J1NN745, 01-01-0564 01010564CNN656, 01-01-0564 01010564C3NN658, 01-01-0564 01010564CNN659, 01-01-0564 01010564DNN671, 01-01-0564 01010564D1NN681, 01-01-0564 01010564ENN697, 01-01-0564 01010564E2NN698, 01-01-0564 01010564FNN733, 01-01-0564 01010564G1NN744, 01-01-0564 01010564GNN746, 01-01-0566 01010566CNN663, 01-01-0566 01010566BNN670, 01-01-0566 01010566BNN671, 01-01-0566 01010566BNN688, 01-01-0566 01010566BNN689, 01-01-0566 01010566DNN699, 01-01-0566 01010556E1NN726, 01-01-0566 01010556E1NN727,
Synovo Production is recalling ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Refere due to Medical device components were marketed without FDA clearance and without FDA approval. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medical device components were marketed without FDA clearance and without FDA approval
Recommended Action
Per FDA guidance
On March 21, 2024, Synovo Production issued a "Urgent Medical Device Recall" notification to affected consignees. Synovo asked consignees to take the following actions: 1. The affected devices should not be used in patients at this time; therefore, please quarantine and return all Acetabular Fixation Cups, Acetabular Bearings, and Femoral Resurfacing Cups. Please complete the enclosed recall response form detailing the affected current products that are in your possession. Be sure to follow the outlined steps: 1a) Segregate and quarantine the products; 2b) Please contact us with the return shipment carton quantity as well as the weight. We will provide a return label for shipping; 3c) Notify your consignees others within your network that may have received these devices and disseminate to them a copy of this communication. instruct them to identify and segregate any affected product from their inventory for return to Synovo. 2. Work with consignees to determine if any of the potential risks identified above from the modified devices have been experienced. Report this adverse event information directly to the manufacturer and/or FDA by completing the MedWatch Voluntary Reporting Form. 3. For any additional details see recall notification.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026