Ottobock MagValve Recall for Prosthetic Socket Air Evacuation Defect
Ottobock is recalling 110 MagValve units used in prosthetic sockets because some valve inserts have a smaller diameter than specified.
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, and the defect is a dimensional specification issue with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ottobock Orthopedic Industrie is recalling 110 units of the 21Y15 MagValve. This product is a threadless one-way valve intended exclusively for the prosthetic fitting of lower limb amputees to evacuate air from the prosthetic socket.
The recall was initiated because some of the installed valve-inserts have a diameter smaller than the specification. The affected products were delivered between May 1, 2017, and January 19, 2018, and were distributed nationwide in the United States.
Consumers who have this product should contact the recalling firm for further instructions on how to proceed.
The recalled product
- 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.
- Manufacturer
- Ottobock Orthopedic Industrie
- Category
- Medical Device — Prosthetics
- Hazard
- Affected units
- 110
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 Recall for Diameter Specification Defect
FDA (Devices) · 2019-02-20
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FDA (Devices) · 2019-02-20
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