Ossur Americas: Medical Device Recall in 2022 - (Recall #: Z-1330-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.

Product Classification:

Class II

Date Initiated: May 30, 2022

Date Posted: July 13, 2022

Recall Number: Z-1330-2022

Event ID: 90312

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.

Status: Terminated

Product Quantity: 410 devices

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

Distribution Pattern:

Worldwide distribution including US nationwide (including Puerto Rico).

Voluntary or Mandated:

Voluntary: Firm initiated