FDA Device recall Z-0827-2019
21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb ampu…
- FDA Device
- Class II
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class II recall of 21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb ampu… by Ottobock Orthopedic Industrie, citing some of the installed valve-inserts have a diameter smaller than the specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0827-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-10 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ottobock Orthopedic Industrie |
| Distribution | US |
Product
21Y14=S PushValve upper part 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.
Reason
Some of the installed valve-inserts have a diameter smaller than the specification.
Identifiers
| code_info | The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0827-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.