CLASS II Device recall · Reported 13 Oct 2021 · FDA Enforcement Report

ARCH Leg Positioning System recalled by Innovative Orthopedic

Innovative Orthopedic Technologies is recalling ARCH Leg Positioning System, distributed nationwide in the US. The recall was initiated on 13 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: 6813010 Serial Numbers: 6813010.0066; 6813010.0067; 6813010.0069; 6813010.0070; 6813010.0071; 6813010.0072; 6813010.0073; 6813010.0074; 6813010.0075; 6813010.0076;

Quantity recalled10 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0072-2022
FDA event ID: 88636
Recalling firm: Innovative Orthopedic Technologies, Winnie, TX
Classification: Class II
Status: Terminated
Recall initiated: 13 Sep 2021
FDA classified: 7 Oct 2021
Reported: 13 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Sep 2021	Recall initiated by company
7 Oct 2021	Classified by FDA	+24 days
13 Oct 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

ARCH Leg Positioning System

Where it was distributed

U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX.

Nationwide Alabama Arizona Florida Michigan Minnesota Oklahoma South Dakota Texas

Questions about this recall

Is ARCH Leg Positioning System recalled?

Yes. Innovative Orthopedic Technologies recalled ARCH Leg Positioning System on 13 Sep 2021. The recall is Class II and its status is Terminated. Recall number Z-0072-2022.

Why was it recalled?

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

Which lots are affected?

Model: 6813010 Serial Numbers: 6813010.0066; 6813010.0067; 6813010.0069; 6813010.0070; 6813010.0071; 6813010.0072; 6813010.0073; 6813010.0074; 6813010.0075; 6813010.0076;

Where was it sold?

U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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