FDA Medical Device Recalls (openFDA)
Otto Bock Healthcare GmbH: 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.
- Recall number
- Z-2261-2015
- Recalling firm
- Otto Bock Healthcare GmbH
- 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.
- Status
- Terminated
- Initiated
- 2015-07-16
- Posted
- 2015-07-24
- Terminated
- 2017-06-21
- Reason
- 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.
- Root cause
- Component design/selection
- Action
- The firm, Ottobock, sent an "URGENT MEDICAL DEVICE RECALL 3R62 Pheon" letter dated 16 July 2015 to its customers. The letter described the product, problem, and actions to be taken. The customers instructed to read this notice in its entirety; examine your stock for 3R62 Pheon devices; quarantine 3R62 Pheon devices and prevent further distribution; contact Ottobock customer service at (800) 328-4058-option 1 or (512) 806-2000 -Option 1, to obtain a return authorization for those devices, and complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form via email to: USRecalls@ottobock.com "Pheon Recall"; fax (801) 974-6718-"Pheon Recall" or mail to: Otto Bock HealthCare LP, ATTN: PHEON RECALL, 3820 W. Great Lakes Drive, Salt Lake City, UT 84120-B7 is re-designing the locking function to prevent this failure from occurring. The re-designed devices will be available for replacement sometime within the next few months. If you have any questions contact Director, Regulatory & Quality Compliance at (801) 974-6618 or email: Lex.Pearce@ottobock.com.
- Quantity
- 518 (439 US; 79 OUS)
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.
- Lot, serial or model codes
- The removal affects all devices manufactured and distributed since February 2014.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ISY
- Firm FEI
- 3003117657
- Firm city
- Duderstadt
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28