FDA Medical Device Recalls (openFDA)
Ottobock Orthopedic Industrie: 21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
- Recall number
- Z-0828-2019
- Recalling firm
- Ottobock Orthopedic Industrie
- Product
- 21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
- Status
- Terminated
- Initiated
- 2019-01-10
- Posted
- not on file
- Terminated
- 2021-06-22
- Reason
- Some of the installed valve-inserts have a diameter smaller than the specification.
- Root cause
- Process control
- Action
- The firm initiated the recall by email on 01/10/2019 and followed with a letter on 01/11/2019. The letter identified the affected product, problem, actions to be taken and that a second letter with the replacement unit was forthcoming.
- Quantity
- 110 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ISY
- Firm FEI
- 3004024451
- 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