Recall Z-0827-2019— Ottobock Orthopedic Industrie
Class II · Terminated
Class II FDA medical device recall by Ottobock Orthopedic Industrie, initiated 2019-01-10, terminated 2021-06-22. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Ottobock Orthopedic Industrie
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-01-10
- Terminated
- 2021-06-22
- Firm location
- Duderstadt, N/A, Germany
Product description
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 for recall
Some of the installed valve-inserts have a diameter smaller than the specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.