ARCH Leg Positioning System recalled due to locking pin engagement failure
Innovative Orthopedic Technologies is recalling the ARCH Leg Positioning System due to manufacturing defects that prevent locking pins from properly engaging under load.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a manufacturing defect that prevents locking pins from engaging properly under load. The defect creates a risk of positioning failure and instability, meeting the rubric criterion for 'risk-of-harm products' at High severity.
Plain-English summary
The ARCH Leg Positioning System (Model 6813010) is being recalled by Innovative Orthopedic Technologies, LLC. The recall affects 10 units distributed nationwide in Alabama, Arizona, Florida, Michigan, Minnesota, Oklahoma, South Dakota, and Texas.
The manufacturer has identified a manufacturing defect: the mounting holes were not bored to the correct diameter. This defect prevents the locking pins from properly engaging when the device is under load, which could result in loss of positioning stability.
Patients and healthcare facilities currently using this device should stop using it and contact the manufacturer. Verify whether your device has one of these affected serial numbers: 6813010.0066, 6813010.0067, 6813010.0069, 6813010.0070, 6813010.0071, 6813010.0072, 6813010.0073, 6813010.0074, 6813010.0075, or 6813010.0076.
The recalled product
- Product
- ARCH Leg Positioning System
- Manufacturer
- Innovative Orthopedic Technologies, LLC
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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
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