Synovo Production: 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

Recall number

Z-1498-2024

Recalling firm

Synovo Production

Product

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

Status

Open, Classified

Initiated

2023-05-30

Posted

2024-04-08

Terminated

not on file

Reason

Medical device components were marketed without FDA clearance

Root cause

No Marketing Application

Action

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.

Quantity

496 units

Distribution

US Nationwide distribution in the state of WA.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

KXB

Firm FEI

2280596

Firm city

Fullerton

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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