Pega Medical Inc. 1111 Chomedey (A-13) E Laval Canada SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.

Recommended Action

Per FDA guidance

Pega Medical notified customers of the recall on about 10/02/2019, via "Urgent Field Safety Notice - Recall" letter. Customers were informed that SCFE Drivers, 6.5mm and 7.3 mm of the Free Gliding SCFE Screw System had issues with the knobs. Specifically the knobs have the potential to have loosened screws, or screws that have fallen out, as a result of the ultrasonic cleaning of the knobs. Customers were instructed to identify affected devices in inventory and return them to Pega Medical as soon as possible to address the issue. There returned devices can be returned via the FedEx information provided in the recall letter. Additionally customers were requested to provide the recall notification to all who need to be notified within your organization or any organization where the affected devices have been transferred. Contacts for questions include Mr. Enrique Garcia, at 450-688-5144 Ext 242, Email: egarcia@pegamedical.com and Mr. Kildare Molina, at 450-688-5144 Ext. 267, Email: kildare@pegamedical.com.