OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
FDA Device Recall #Z-1330-2022 — Class II — May 30, 2022
Recall Summary
| Recall Number | Z-1330-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 30, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ossur Americas |
| Location | Foothill Ranch, CA |
| Product Type | Devices |
| Quantity | 410 devices |
Product Description
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
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.
Distribution Pattern
Worldwide distribution including US nationwide (including Puerto Rico).
Lot / 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
Other Recalls from Ossur Americas
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1821-2022 | Class II | OSSUR Power Knee REF PKA10003 OSSUR Power Kn... | Aug 29, 2022 |
| Z-0380-2022 | Class II | Miami J Select Collar, Item: MJS-101, and Miami... | Nov 9, 2021 |
| Z-1896-2021 | Class II | OSSUR MIAMI J SELECT COLLAR - Product Usage: is... | Jun 1, 2021 |
| Z-0997-2019 | Class II | Ossur Skull Pin, Sterile Titanium Pin, Part/... | Jun 21, 2018 |
| Z-1003-2019 | Class II | Ossur, ReSolve Halo Vest, Part/ Description:... | Jun 21, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.