Ossur recalls Icelock 125, 600XM, and 621 Ratchets due to potential pin disengagement causing prosthetic loss and falls. Affected units include specific model references and production lots.
A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected, leading to the potential for the pin to disengage from the lock, leading to loss of suspension of the external prosthetic system that replaces a missing lower limb, which can lead to falling and injury.
Ossur is recalling Icelock 125, 600XM, and 621 Ratchet prosthetic components because a worn attachment pin could disengage, causing the prosthetic to lose connection and potentially leading to falls or injury. This affects users who rely on these devices for lower limb replacement.
The attachment pin in the ratchet lock can wear down faster than expected, which may cause it to disengage from the lock mechanism. This could lead to the prosthetic losing its connection to the user's body, resulting in a fall or injury.
Users of Ossur's Icelock ratchets for lower limb prosthetics are most at risk, particularly those with specific model references and production lots listed in the recall.
Check if your prosthetic has the Icelock 125 Ratchet (REF L-125000), Icelock 600XM Ratchet (REF L-621200), or Icelock 621 Ratchet (REF L-621000). Also, verify your product's production lot number matches the listed lots: HF210205, HF210519, HF211008, HF220303, MX210518, MX210816, MX210823, MX211022, MX220316.
Identify your ratchet model and production lot number to confirm if it's affected by this recall.
The recall affects Icelock 125 Ratchet (REF L-125000), Icelock 600XM Ratchet (REF L-621200), and Icelock 621 Ratchet (REF L-621000).
Check your product's reference number and production lot against the listed references: L-125000/05690967566142, L-621200/05690967596590, L-621000/05690967118334, and production lots HF210205 through MX220316.
The recall does not specify a remedy, so contact Ossur directly for guidance on next steps.
We’ve drafted a message you can send Ossur to request your refund or repair — edit it as you like.
Subject: Recall Z-1906-2023 — Ossur Ossur Hello, I own a Ossur that is covered by recall Z-1906-2023 from Ossur. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
