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

FDA device recall Z-1497-2024 · posted 2024-04-08 · Open, Classified

Recall details

Recalling firm

Synovo Production

Reason for recall

Medical device components were marketed without FDA clearance

Action taken

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.

Root cause

No Marketing Application

Status

Open, Classified

Product code

KXB

Quantity affected

1681 units

Distribution

US Nationwide distribution in the state of WA.

Date initiated

2023-05-30

Date posted

2024-04-08

Location

Fullerton, CA