FDA Device recall Z-1906-2023
Icelock 125 Ratchet, REF: L-125000
- FDA Device
- Class II
- ongoing
- Published 2023-06-21
On 2023-06-21 the FDA classified a Class II recall of Icelock 125 Ratchet, REF: L-125000 by Ossur H F, citing 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 pote….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1906-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-12 |
| Published | 2023-06-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ossur H F |
| Distribution | 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 |
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.
Identifiers
| code_info | REF/UDI-DI: L-125000/05690967566142; L-621200/05690967596590; L-621000/05690967118334; L-621100/05690967155322; L-69202…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1906-2023%22
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