Icelock 125 Ratchet — Class II medical device recall Z-1906-2023
Ongoing recall by Ossur H / F, reported 2023-06-21, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin
| Recall number | Z-1906-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ossur H / F, Reykjavik, N/A, Iceland |
| Recall initiated | 2023-05-12 |
| Classified | 2023-06-13 |
| Reported by FDA | 2023-06-21 |
| Distributed | 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 |
| Quantity | 4,190 |
| UPC / GTIN / UDI-DI | 05690967118334, 05690967128548, 05690967155322, 05690967566142, 05690967596590 |
| Lot numbers | HF210205, HF210519, HF211008, HF220303, MX210518, MX210816, MX210823, MX211022, MX220316 |
| Model numbers | L-125000, L-621000, L-621100, L-621200, L-692020 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1906-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.