Z-0072-2022Class II

ARCH Leg Positioning System

Name: Z-0072-2022 ARCH Leg Positioning System
Creator: Innovative Orthopedic Technologies, LLC
Published: 2021-09-13
License: https://open.fda.gov/license/

Innovative Orthopedic Technologies, LLC / initiated 2021-09-13 / Terminated / root cause: design

FDA source

Innovative Orthopedic Technologies, LLC began a recall of ARCH Leg Positioning System on 2021-09-13. FDA classified it as Class II and gives the reason as "Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0072-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-13
Posted: 2021-10-07
Terminated: 2024-01-29
Recalling firm: Innovative Orthopedic Technologies, LLC
Product: ARCH Leg Positioning System
Product code: BWN Table And Attachments, Operating-Room
Reason for recall: Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected] or mail at 1115 Hwy 124, Winnie, TX 77665 email www.iotiot.com
Quantity in commerce: 10 units
Distribution: U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX.
Product codes and lots: Model: 6813010 Serial Numbers: 6813010.0066; 6813010.0067; 6813010.0069; 6813010.0070; 6813010.0071; 6813010.0072; 6813010.0073; 6813010.0074; 6813010.0075; 6813010.0076;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0072-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0072-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-07

Product code BWN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)