ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 0...
FDA Device Recall #Z-1497-2024 — Class II — May 30, 2023
Recall Summary
| Recall Number | Z-1497-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 30, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Synovo Production |
| Location | Fullerton, CA |
| Product Type | Devices |
| Quantity | 1681 units |
Product Description
ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266
Reason for Recall
Medical device components were marketed without FDA clearance
Distribution Pattern
US Nationwide distribution in the state of WA.
Lot / Code Information
UDI/REF Number: 00814193025906/01-02-4254; 00814193025913/01-02-4456; 00814193025920/01-02-4558; 00814193025937/01-02-4760; 00814193025968/01-02-4962; 00814193025944/01-02-5164; 00814193025951/01-02-5266; REF Number/Lot Number: 01-02-4254 01024254FNN612, 01-02-4254 01024254FNN613, 01-02-4254 01024254GNN614, 01-02-4254 01024254FNN620, 01-02-4254 01024254GNN623, 01-02-4254 01024254FNN644, 01-02-4254 01024254NN651, 01-02-4254 01024254NN652, 01-02-4254 01024254NN741, 01-02-4456 01024456ENN613, 01-02-4456 01024456FNN614, 01-02-4456 01024456ENN620, 01-02-4456 01024456FNN620, 01-02-4456 01024456FNN623, 01-02-4456 01024456ENN644, 01-02-4456 01024456FNN644, 01-02-4456 01024456ENN650, 01-02-4456 01024456FNN650, 01-02-4456 01024456NN651, 01-02-4456 01024456NN652, 01-02-4456 01024456NN656, 01-02-4456 01024456NN728, 01-02-4458 01024458NN651, 01-02-4458 01024458NN652, 01-02-4558 01024558FNN614, 01-02-4558 01024558FNN623, 01-02-4558 01024558NN629, 01-02-4558 01024558HNN686, 01-02-4558 01024558HNN692, 01-02-4558 01024558JNN698, 01-02-4760 01024760FNN614, 01-02-4760 01024760ENN616, 01-02-4760 01024760ENN620, 01-02-4760 01024760FNN620, 01-02-4760 01024760FNN623, 01-02-4760 01024760ENN625, 01-02-4760 01024760FNN644, 01-02-4760 01024760NN651, 01-02-4760 01024760NN652, 01-02-4760 01024760NN654, 01-02-4760 01024760NN656, 01-02-4760 01024760HNN698, 01-02-4760 01024760HNN728, 01-02-4760 01024760HNN741, 01-02-4962 01024962FNN614, 01-02-4962 01024962ENN616, 01-02-4962 01024962FNN622, 01-02-4962 01024962NN624, 01-02-4962 01024962NN628, 01-02-4962 01024962NN645, 01-02-4962 01024962ENN654, 01-02-4962 01024962NN668, 01-02-4962 01024962NN670, 01-02-4962 01024962HNN686, 01-02-4962 01024962HNN723, 01-02-4962 01024962NN734, 01-02-4962 01024962NN735, 01-02-5164 01025164ENN614, 01-02-5164 01025164ENN620, 01-02-5164 01025164ENN622, 01-02-5164 01025164NN634, 01-02-5164 01025164NN649, 01-02-5164 01025164NN656, 01-02-5164 01025164NN669, 01-02-5164 01025164GNN678, 01-02-5164 01025164GNN680, 01-02-5164 01025164GNN691, 01-02-5164 01025164HNN695, 01-02-5164 01025164HNN697, 01-02-5164 01025164JNN733, 01-02-5164 01025164JNN743, 01-02-5266 01025266NN639, 01-02-5266 01025266NN654, 01-02-5266 01025266NN656, 01-02-5266 01025266CNN664, 01-02-5266 01025266CNN670, 01-02-5266 01025266CNN691, 01-02-5266 01025255CNN692, 01-02-5266 01025266DNN698, 01-02-5266 01025266ENN733,
Other Recalls from Synovo Production
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1498-2024 | Class II | Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI... | May 30, 2023 |
| Z-1496-2024 | Class II | ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI... | May 30, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.