Ottobock PushValve Recall for Diameter Specification Defect
Ottobock is recalling 538 PushValve units because some valve inserts have a diameter smaller than the specification. The valve is used for prosthetic fitting of lower limb amputees.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect is a dimensional specification issue without reported injuries or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Ottobock Orthopedic Industrie is recalling 538 units of the 21Y14 PushValve. The recall is due to a defect where some of the installed valve-inserts have a diameter smaller than the specification. The PushValve is a threadless one-way valve intended exclusively for the prosthetic fitting of lower limb amputees to evacuate air from the prosthetic socket.
The affected products were delivered between May 1, 2017, and January 19, 2018. The recall covers products with the specific article number listed in the official notice and distributed nationwide in the United States.
Consumers who have this product should stop using it and contact Ottobock Orthopedic Industrie for instructions on how to proceed with the recall.
The recalled product
- Product
- 21Y14 PushValve 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.
- Manufacturer
- Ottobock Orthopedic Industrie
- Hazard
- Affected units
- 538
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- The products with an article number listed below and delivered between May 1
- 2017 and January 19
- 2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Ottobock Orthopedic Industrie under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Ottobock Orthopedic Industrie
See all →- ModerateOttobock PushValve Upper Part Recalled for Diameter Specification Defect
FDA (Devices) · 2019-02-20
- ModerateOttobock MagValve Recall for Prosthetic Socket Air Evacuation Defect
FDA (Devices) · 2019-02-20
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