Use caution Medical device recall · FDA · Published May 30, 2022

Ossur VARIFLEX SUBA JUNIOR Prosthetic Foot Recall: Cracks Cause Breakage Under Impact

Ossur recalls children's and adolescent foot and ankle prostheses (VARIFLEX SUBA JUNIOR) due to cracks that can break under sudden twisting or bending forces.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1330-2022Medical device Ossur ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmOssur Americas27051 Towne Centre Dr · Foothill Ranch, CA 92610-2804

✎ GovInfoNow plain-language explainer

Ossur is recalling its VARIFLEX SUBA JUNIOR foot and ankle prostheses for children and adolescents because they can crack under sudden high-impact twisting or bending. This crack risk could lead to the prosthesis breaking during normal use, potentially causing injury. Read more at govinfonow.com/recall/60577-ossur-variflex-suba-junior-prosthetic-foot-recall-cracks-cause-breakage.

Source Summary by GovInfoNow · govinfonow.com/recall/60577-ossur-variflex-suba-junior-prosthetic-foot-recall-cracks-cause-breakage · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1330-2022

Cite this page

“Ossur VARIFLEX SUBA JUNIOR Prosthetic Foot Recall: Cracks Cause Breakage Under Impact.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60577-ossur-variflex-suba-junior-prosthetic-foot-recall-cracks-cause-breakage. Based on FDA recall #Z-1330-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1330-2022%22&limit=1).

The FDA announced on May 30, 2022, that Ossur Americas is recalling the OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis sized for children and adolescents. The agency cited hazards related to broken prosthetic feet due to sudden high impact twisting or bending.

How to tell if you have it

Brand: Ossur
Product: OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis
Item Numbers/UDI-DI Codes: VJB0116L (5690977387201), VJB0116R (5690977387218), VJB0117L (5690977387225), VJB0117R (5690977387232), VJB0118L (5690977387249), VJB0118R (5690977387256), VJB0119L (5690977387263), VJB0119R (5690977387270), VJB0218L (5690977387287), VJB0218R (5690977387294), VJB0219L (5690977387300), VJB0219R (5690977387317), VJB0220L (5690977387324), VJB0220R (5690977387331), VJB0221L (5690977387348), VJB0221R (5690977387355), VJB0222L (5690977387362), VJB0222R (5690977387379), VJB0223L (5690977387386), VJB0223R (5690977387393), VJB0319L (5690977241251), VJB0319R (5690977241282), VJB0320L (5690977387409), VJB0320R (5690977387416), VJB0321L (5690977387423), VJB0321R (5690977387430), VJB0322L (5690977387447), VJB0322R (5690977387454), VJB0323L (5690977387461), VJB0323R (5690977387478), VJB0324L (5690977387485), VJB0324R (5690977387492), VJB0420L (5690977241312), VJB0420R (5690977241343), VJB0421L (5690977241374), VJB0421R (5690977241404), VJB0422L (5690977387508), VJB0422R (5690977387515), VJB0423L (5690977387522), VJB0423R (5690977387539), VJB0424L (5690977387546), VJB0424R (5690977387553)
Units affected: 410 devices
Distribution: Worldwide including US nationwide

The hazard

The recall is due to complaints regarding broken or cracked prosthetic feet. Failures occurred in situations where sudden high impact twisting or bending was applied to the foot.

Context

GovInfoNow's records show Ossur Americas has 4 other recalls on record since 2018-06-21. Other recent recalls of similar products include Zimmer Affixus Femoral Nails Recall (2025-12-02) and Paragon 28 Custom Foot Implant Recall (2026-07-10).

How to tell if you have this one

Check for the model numbers listed in the recall: VARIFLEX JUNIOR C1, C2, or C3 with sizes S16 through S24. These prostheses were sold between 2019 and 2023.

Brand
Ossur
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Cracks
Inspect the prosthetic foot for visible cracks or damage before using it.
Stop Using Immediately
If cracks are found, stop using the prosthesis right away to prevent injury.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution including US nationwide (including Puerto Rico).” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

May 30, 2022Firm started the recall
Jul 5, 2022FDA classified it Class II
Jul 13, 2022Published in FDA’s Enforcement Report
Dec 27, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/60577-ossur-variflex-suba-junior-prosthetic-foot-recall-cracks-cause-breakage">Ossur VARIFLEX SUBA JUNIOR Prosthetic Foot Recall: Cracks Cause Breakage Under Impact (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1330-2022 (May 30, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1330-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.