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.
What this means for you
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
- Hazard
- mechanical-failure
- suspension-loss
- fall-injury
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:
- AL
- AR
- AZ
- CA
- CO
- CT
- DE
- FL
- GA
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- MS
- MT
- NC
- NE
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- SC
- SD
- TN
- TX
- UT
- VA
- WA
- WI
- WV
- WY
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