CLASS II Device recall · Reported 20 Feb 2019 · FDA Enforcement Report
21Y15 MagValve recalled by Ottobock Orthopedic Industrie
Ottobock Orthopedic Industrie is recalling 21Y15 MagValve, distributed nationwide in the US. The recall was initiated on 10 Jan 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0828-2019
- FDA event ID
- 81926
- Recalling firm
- Ottobock Orthopedic Industrie, Duderstadt, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jan 2019
- FDA classified
- 13 Feb 2019
- Reported
- 20 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Jan 2019 | Recall initiated by company | |
| 13 Feb 2019 | Classified by FDA | +34 days |
| 20 Feb 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some of the installed valve-inserts have a diameter smaller than the specification.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Some of the installed valve-inserts have a diameter smaller than the specification.
Which lots are affected?
The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 81926| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 21Y14 PushValve recalled by Ottobock Orthopedic Industrie | Ottobock Orthopedic Industrie | Other | Nationwide | |
| CLASS II | 21Y14=S PushValve upper part recalled by Ottobock Orthopedic Industrie | Ottobock Orthopedic Industrie | Other | Nationwide |
More recalls from Ottobock Orthopedic Industrie
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 21Y14=S PushValve upper part recalled by Ottobock Orthopedic Industrie | Ottobock Orthopedic Industrie | Other | Nationwide |
| Device | CLASS II | 21Y14 PushValve recalled by Ottobock Orthopedic Industrie | Ottobock Orthopedic Industrie | Other | Nationwide |
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