Recall Z-1330-2022 ยท ISH Component, External, Limb, Ankle/Foot
Ossur Americas
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
| Date | May 30, 2022 |
| Status | Terminated |
| Reason | Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is applied to the foot. |
| Root cause | Other |
| Action | On 05/30/2022, Ossur sent an "URGENT FIELD SAFETY NOTICE" via email informing customers that Ossur received customer complaints related to broken Vari-Flex Junior feet with failures occurring in situations where sudden high impact twisting or bending is applied to the foot. Such circumstances can happen in sports activities, including for example football/soccer. To ensure compliance and user safety the Instructions for Use, IFU 1121_001 for Vari-Flex Junior, have been updated from version 6 to version 7 to include the additional information required. The specific updates are outlined/highlig |
| Quantity | 410 devices |
| Distribution | Worldwide distribution including US nationwide (including Puerto Rico). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.