Recall Z-1906-2023— Ossur H / F
Class II · Ongoing
Class II FDA medical device recall by Ossur H / F, initiated 2023-05-12. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- Ossur H / F
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-12
- Firm location
- Reykjavik, N/A, Iceland
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.