Innovative Orthopedic Technologies, LLC ARCH Leg Positioning System Recall

Check Your Product

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

Reason for Recall

As stated by FDA

Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.

Recommended Action

Per FDA guidance

On 09/13/2021, the firm sent via certified mail an "URGENT: MEDICAL DEVICE RECALL" Notification letter to customers informing them that the Leg Positioning System is being recalled due to a manufacturing defect that may make locking the flexion/extension carriage into position difficult under load. Customers are instructed to: 1. Contact the Recalling Firm to schedule repair of their device. 2. While customers are waiting for the repair of their device, lifting the boot to lighten the load will pushing the locking pin into place can alleviate the issue. 3. Complete and return the Acknowledgement and Receipt Form to the Recalling Firm by email or mail. The actions the Recalling Firm is taking: 1. Correcting the issue by temporarily replacing the affected part with an unaffected part while the affected part is being repaired. The repair will be taking place at the Recalling Firm's facility. 2. Implementing an additional functional test that will test the product under load. For questions and to schedule repair, contact: Suzanne Janacek, Operations Director - 409-658-1017 Monday through Friday 8:00 AM to 4:30 PM Central Time or email suzanne.janacek@iotiot.com or mail at 1115 Hwy 124, Winnie, TX 77665 email www.iotiot.com