Otto Bock Recalls Pheon 3R62 Polycentric Prosthetic Knee Joints
Otto Bock Healthcare GmbH is voluntarily recalling 3R62 Pheon prosthetic knee joints because the locking function may fail, potentially causing a fall.
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: The recall involves a risk-of-harm product (prosthetic knee) where injury (fall) has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014. The recall involves 518 units, with 439 distributed in the United States and 79 distributed outside the US. The devices are intended for lower limb prosthetic fittings.
The recall is being conducted because the locking function of the knee joints may fail under certain conditions. This failure may result in a fall for the user.
The affected devices were distributed worldwide, including in the United States (nationwide) and in Australia, Belgium, China, Czechia, Italy, the Netherlands, and Slovakia. Consumers and healthcare providers should contact Otto Bock Healthcare GmbH for instructions on how to address the defect.
The recalled product
- Product
- Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
- Manufacturer
- Otto Bock Healthcare GmbH
- Hazard
Distribution
Distributed nationwide across the United States.
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