Device product

ARCH Leg Positioning System

Z-0072-2022

September 13, 2021

Class II

Product summary

Firm: Innovative Orthopedic Technologies, LLC
Event: Event 88636
Status: Terminated
Classification: Class II
Quantity: 10 units
Official record key: device-enforcement:Z-0072-2022

Official wording

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

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

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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