Class 2 Device Recall VariFlex Junior

• Date Initiated by Firm: May 30, 2022
• Create Date: July 05, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1330-2022
• Recall Event ID: 90312
• Product Classification: Component, external, limb, ankle/foot - Product Code ISH
• Product: OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
• Code Information: 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
• Recalling Firm/ Manufacturer: Ossur Americas; 27051 Towne Centre Dr; Foothill Ranch CA 92610-2804
• For Additional Information Contact: Chris Lohrman,; 949-382-3715 Ext. 102
• Manufacturer Reason for Recall: 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.
• FDA Determined 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/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 patient¿s 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
• Quantity in Commerce: 410 devices
• Distribution: Worldwide distribution including US nationwide (including Puerto Rico).
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.