—#210607

Product

CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A

FDA product code: OJH — Orthopedic Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI-DI:10889942848447; Lot Number: 24EBP466

Why it was recalled

Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

An URGENT MEDICAL DEVICE NOTIFICATION dated 10/4/24 was sent to the customer. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately.2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.The login for completing the response form is:Website link: https://recalls.medline.comRecall Reference #: R-24-207-FGX1Recall Code: 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution in the state of TN.

Timeline

Recall initiated: 2024-10-04
Posted by FDA: 2024-11-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210607. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.