OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
Recall
- Recall Number
- Z-1330-2022
- Event Number
- 90312
- Firm
- Ossur Americas
- FEI Number
- 1000519909
- Product Code
- ISH
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 30, 2022
- Terminated
- December 27, 2024
- Address
- 27051 Towne Centre Dr, Foothill Ranch, CA, 92610-2804
Description
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
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.
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/highlighted in yellow. Action require of customers are: 1. Please monitor and review the activities of those patients that have already been fitted with the Vari-Flex Junior. If the Vari-Flex Junior is not suitable, another type of device or an additional foot should be considered, depending on the patients needs. 2. Please ensure the updated Instructions for Use and this notice are distributed to the necessary persons within the organization. A copy of the updated instructions accompanies this notice. 3. Please pass this notice to those who need to be aware within your organization or to any organization where Vari-Flex Junior devices have been transferred. 4. Please retain this letter in a prominent position for one month. 5. If you have further distributed this product, please identify your customers, and notify them at once of this Field Safety Notice. We recommend that you include a copy of this notice. 6. Reply to the email/mail that you received confirming receipt of this notice and the updated instructions for use, as we require this information to reconcile this process. For questions, UNITED STATES can contact Ossur Americas at 1-800-233-6263
Worldwide distribution including US nationwide (including Puerto Rico).
410 devices