OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
Check against the official notice below — it lists the full affected range.
Ossur Americas is recalling 410 Variflex Suba Junior prosthetic feet designed for children and adolescents. The recall was initiated due to complaints about the prosthetic feet cracking or breaking when exposed to sudden high-impact twisting or bending forces. The affected devices have been distributed worldwide, including throughout the United States and Puerto Rico.
The recalled prosthetics are identified by specific item numbers and UDI-DI codes ranging from VJB0116L through VJB0324R in various sizes (S16 through S23) and categories (C1, C2, and C3). The source document does not specify a remedy or instructions for what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Worldwide distribution including US nationwide (including Puerto Rico). Quantity: 410 devices Lot/code info: 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 J
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.