Agency classClass IIOur severity:High FDA (Devices)·Z-1906-2023·Announced 2023-06-21

Prosthetic Socket Ratchet Locking Systems Recalled for Suspension Loss Risk

Mechanical locking devices for prosthetic sockets may develop accelerated wear that causes the attachment pin to disengage, potentially leading to loss of prosthetic suspension and falls.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for mechanical failure in prosthetic locking components where the device can fail leading to falls and injury. This is classified as High per the rubric: risk-of-harm product where injury has not yet been reported in the source material.

Plain-English summary

Ossur H/F is recalling prosthetic socket ratchet locking systems used to connect and release locking liners in prosthetic sockets that replace missing lower limbs. The affected products include the Icelock 125, Icelock 600XM, Icelock 621, and related components.

The attachment pins and locks in these devices can wear down faster than expected. When this wear occurs, the pin may disengage from the lock, causing loss of suspension of the prosthetic system. This can result in the prosthetic becoming unstable and potentially leading to falls and injury.

The recall affects approximately 4,190 units distributed across the United States and Puerto Rico. Affected lot numbers include HF210205, HF210519, HF211008, HF220303, MX210518, MX210816, MX210823, MX211022, and MX220316.

The recalled product

Product: Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020
Manufacturer: Ossur H / F
Category: Medical Device — Prosthetic Components
Hazard: mechanical-failure
suspension-loss
fall-injury
Affected units: 4,190

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

REF/UDI-DI: L-125000/05690967566142
L-621200/05690967596590
L-621000/05690967118334
L-621100/05690967155322
L-692020/05690967128548. Lots: HF210205
HF210519
HF211008
HF220303
MX210518
MX210816
MX210823
MX211022
MX220316.

Distribution

Distributed in 44 states:

Same manufacturer · Ossur H / F

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