PlainRecordsFDA · Medical device recall
21Y14 PushValve Product Usage: The PushValves/ MagValves is intended… and 2 more products
- Date
- Feb. 20, 2019
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): 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)
- Status
- Terminated
- Filed by
- Ottobock Orthopedic Industrie
- Reason
- Some of the installed valve-inserts have a diameter smaller than the specification.
- Distribution pattern
- US Nationwide Distribution
3 products in this recall
21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting…
- 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.
- Quantity
- 538 units
- Codes and lots
- The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018
- Recall started
- Jan. 10, 2019
- Device type
- Joint, Knee, External Limb Component
- Root cause (FDA)
- Process control
- What the company told customers
- 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.
- Recall number
- Z-0826-2019
21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the…
- 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.
- Quantity
- 1 unit
- Codes and lots
- The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018
- Recall started
- Jan. 10, 2019
- Device type
- Joint, Knee, External Limb Component
- Root cause (FDA)
- Process control
- What the company told customers
- 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.
- Recall number
- Z-0827-2019
21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of…
- 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.
- Quantity
- 110 units
- Codes and lots
- The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018
- Recall started
- Jan. 10, 2019
- Device type
- Joint, Knee, External Limb Component
- Root cause (FDA)
- Process control
- What the company told customers
- 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.
- Recall number
- Z-0828-2019
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0826-2019, Z-0827-2019, Z-0828-2019. The agency record governs; check it and the company before acting.