FDAClass IIOctober 13, 2021

ARCH Leg Positioning System recall

ARCH Leg Positioning System

Why was ARCH Leg Positioning System recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models 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;

Product
ARCH Leg Positioning System
Recalling firm
Innovative Orthopedic Technologies, LLC
Quantity
10 units
Distribution
U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX.
Recall date
October 13, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls