Synovo Production: 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

Recall number

Z-1497-2024

Recalling firm

Synovo Production

Product

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

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

1681 units

Distribution

US Nationwide distribution in the state of WA.

Lot, serial or model codes

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.

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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