# FDA recall Z-1906-2023

> **Ossur H / F** · Class II · device recall initiated 2023-05-12.

## 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.

## Distribution

US: SC, FL,NM, PA, VA, CA, TX, MT, UT, OH, NV, KS, MI, GA, IA, WA, TN, AZ, MN, NC, IN, MS, AL, NY, ID, DE, OK, MA, WI, OR, KY, MD, CO, WV, LA, IL, NJ, CT, MO, NE, WY, AR, SD, PR

## Key facts

- **Recall number:** Z-1906-2023
- **Recalling firm:** Ossur H / F
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-12
- **Report date:** 2023-06-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reykjavik, N/A, Iceland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1906-2023

## Citation

> AI Analytics. FDA recall Z-1906-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1906-2023. Source: US FDA. Licensed CC0.

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