The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1610-2014·Announced 2014-05-21

Ortho Development Recalls PS-C Femoral Knee Implant Components

Ortho Development Corporation is recalling five PS-C Femoral Nonporous Rt Sz 6 knee implant components because pegged versions were found in boxes labeled for the pegless version.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a packaging error without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Ortho Development Corporation is recalling five units of the PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604, which is a component of the Balanced Knee System and Balanced Knee Revision System used for total knee arthroplasty procedures. The recall involves Lot No. A131876.

The recall was initiated because a femoral component containing pegs was found in a box designated for the pegless version. This packaging error could lead to the use of the wrong implant component during surgery.

The affected units were distributed nationwide in the United States, specifically in the states of Nevada and Arizona. Healthcare providers and patients should contact Ortho Development Corporation for further instructions regarding the return or replacement of these components.

The recalled product

Product
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
Manufacturer
Ortho Development Corporation
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
5

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 (1)

  • Lot No. A131876

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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