Ossur Americas OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
Brand
Ossur Americas
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Item Number/Item Description/UDI-DI Code VJB0116L VARIFLEX JUNIOR C1 S16 L 5690977387201 VJB0116R VARIFLEX JUNIOR C1 S16 R 5690977387218 VJB0117L VARIFLEX JUNIOR C1 S17 L 5690977387225 VJB0117R VARIFLEX JUNIOR C1 S17 R 5690977387232 VJB0118L VARIFLEX JUNIOR C1 S18 L 5690977387249 VJB0118R VARIFLEX JUNIOR C1 S18 R 5690977387256 VJB0119L VARIFLEX JUNIOR C1 S19 L 5690977387263 VJB0119R VARIFLEX JUNIOR C1 S19 R 5690977387270 VJB0218L VARIFLEX JUNIOR C2 S18 L 5690977387287 VJB0218R VARIFLEX JUNIOR C2 S18 R 5690977387294 VJB0219L VARIFLEX JUNIOR C2 S19 L 5690977387300 VJB0219R VARIFLEX JUNIOR C2 S19 R 5690977387317 VJB0220L VARIFLEX JUNIOR C2 S20 L 5690977387324 VJB0220R VARIFLEX JUNIOR C2 S20 R 5690977387331 VJB0221L VARIFLEX JUNIOR C2 S21 L 5690977387348 VJB0221R VARIFLEX JUNIOR C2 S21 R 5690977387355 VJB0222L VARIFLEX JUNIOR C2 S22 L 5690977387362 VJB0222R VARIFLEX JUNIOR C2 S22 R 5690977387379 VJB0223L VARIFLEX JUNIOR C2 S23 L 5690977387386 VJB0223R VARIFLEX JUNIOR C2 S23 R 5690977387393 VJB0319L VARIFLEX JUNIOR C3 S19 L 5690977241251 VJB0319R VARIFLEX JUNIOR C3 S19 R 5690977241282 VJB0320L VARIFLEX JUNIOR C3 S20 L 5690977387409 VJB0320R VARIFLEX JUNIOR C3 S20 R 5690977387416 VJB0321L VARIFLEX JUNIOR C3 S21 L 5690977387423 VJB0321R VARIFLEX JUNIOR C3 S21 R 5690977387430 VJB0322L VARIFLEX JUNIOR C3 S22 L 5690977387447 VJB0322R VARIFLEX JUNIOR C3 S22 R 5690977387454 VJB0323L VARIFLEX JUNIOR C3 S23 L 5690977387461 VJB0323R VARIFLEX JUNIOR C3 S23 R 5690977387478 VJB0324L VARIFLEX JUNIOR C3 S24 L 5690977387485 VJB0324R VARIFLEX JUNIOR C3 S24 R 5690977387492 VJB0420L VARIFLEX JUNIOR C4 S20 L 5690977241312 VJB0420R VARIFLEX JUNIOR C4 S20 R 5690977241343 VJB0421L VARIFLEX JUNIOR C4 S21 L 5690977241374 VJB0421R VARIFLEX JUNIOR C4 S21 R 5690977241404 VJB0422L VARIFLEX JUNIOR C4 S22 L 5690977387508 VJB0422R VARIFLEX JUNIOR C4 S22 R 5690977387515 VJB0423L VARIFLEX JUNIOR C4 S23 L 5690977387522 VJB0423R VARIFLEX JUNIOR C4 S23 R 5690977387539 VJB0424L VARIFLEX JUNIOR C4 S24 L 5690977387546 VJB0424R VARIFLEX JUNIOR C4 S24 R 5690977387553
Ossur Americas is recalling OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents. due to Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or ben. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026