Z-0828-2019Class II

21Y15 MagValve

Name: Z-0828-2019 21Y15 MagValve
Creator: Ottobock Orthopedic Industrie
Published: 2019-01-10
License: https://open.fda.gov/license/

Ottobock Orthopedic Industrie / initiated 2019-01-10 / Terminated / root cause: manufacturing process

FDA source

Ottobock Orthopedic Industrie began a recall of 21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless... on 2019-01-10. FDA classified it as Class II and gives the reason as "Some of the installed valve-inserts have a diameter smaller than the specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0828-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-10
Posted: 2019-02-13
Terminated: 2021-06-22
Recalling firm: Ottobock Orthopedic Industrie
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.
Product code: ISY Joint, Knee, External Limb Component
Reason for recall: Some of the installed valve-inserts have a diameter smaller than the specification.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by email on 01/10/2019 and followed with a letter on 01/11/2019. The letter identified the affected product, problem, actions to be taken and that a second letter with the replacement unit was forthcoming.
Quantity in commerce: 110 units
Distribution: US Nationwide Distribution
Product codes and lots: The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0828-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0826-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-13
Z-0827-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-13
Z-0828-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-13

Product code ISY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)