Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a recall
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…
Why was Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a recalled?
Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking function may fail under certain conditions which may result in a fall.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
The removal affects all devices manufactured and distributed since February 2014.
- 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…
- Recalling firm
- Otto Bock Healthcare GmbH
- Quantity
- 518 (439 US; 79 OUS)
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.
- Recall date
- August 5, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)