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Use caution Medical device recall · FDA · Published September 13, 2021

Innovative Orthopedic Technologies ARCH Leg Positioning System recall: Locking pins may

Innovative Orthopedic Technologies recalls ARCH Leg Positioning System model 6813010 with serial numbers 6813010.0066-0076 due to locking pins failing to engage under load, potentially causing injury during use.

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Contact the company

Recalling firmInnovative Orthopedic Technologies, LLC1115 Highway 124 · Winnie, TX 77665
✎ GovInfoNow plain-language explainer

Innovative Orthopedic Technologies is recalling their ARCH Leg Positioning System model 6813010 with specific serial numbers because the locking pins may not engage properly under load. This could lead to the device failing during use, potentially causing injury. Read more at govinfonow.com/recall/61802-innovative-orthopedic-technologies-arch-leg-positioning-system-recall-locking-pins.

Source Summary by GovInfoNow · govinfonow.com/recall/61802-innovative-orthopedic-technologies-arch-leg-positioning-system-recall-locking-pins · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0072-2022

Cite this page

“Innovative Orthopedic Technologies ARCH Leg Positioning System recall: Locking pins may.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61802-innovative-orthopedic-technologies-arch-leg-positioning-system-recall-locking-pins. Based on FDA recall #Z-0072-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0072-2022%22&limit=1).

The FDA announced on September 13, 2021, that Innovative Orthopedic Technologies, LLC is recalling the ARCH Leg Positioning System. The hazard involves locking pins failing to engage under load due to improperly bored holes.

How to tell if you have it

  • Brand: Innovative Orthopedic Technologies
  • Product: ARCH Leg Positioning System
  • 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: U.S. Nationwide in AL, AZ, FL, MI, MN, OK, SD, and TX

The hazard

The holes were not bored to the specific diameter, causing the locking pins to be unable to engage under a load.

Context

GovInfoNow's records show other recent recalls of similar products include U2 Total Knee System Femoral Offset Bushing Recall (2026-03-19), U2 Total Knee System Femoral Valgus Adaptor Recall (2026-05-20), and U2 Total Knee System PSA Box Trial: Incomplete Screw Assembly Risk (2026-05-20).

How to tell if you have this one

Check for the model number 6813010 and serial numbers 6813010.0066 through 6813010.0076 on the device. The product was sold by Innovative Orthopedic Technologies.

  • Brand
    Innovative Orthopedic Technologies
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Serial Number

    Look for the model number 6813010 and serial numbers 6813010.0066 through 6813010.0076 on the device.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 8 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Florida, Michigan, Minnesota, Oklahoma, South Dakota, Texas.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

1. Firm started the recall: Sep 13, 202112. FDA classified it Class II: Oct 7, 202123. Published in FDA’s Enforcement Report: Oct 13, 202134. FDA terminated the recall: Jan 29, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What model and serial numbers are affected?

The affected model is 6813010 with serial numbers 6813010.0066, 6813010.0067, 6813010.0069, 6813010.0070, 6813010.0071, 6813010.0072, 6813010.0073, 6813010.0074, 6813010.0075, and 6813010.0076.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0072-2022 (September 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0072-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA