Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Icelock 125 Ratchet Recalled by Ossur H / F Due to A mechanical lock used to connect and release...

Date: May 12, 2023
Company: Ossur H / F
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ossur H / F directly.

Affected Products

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

Quantity: 4,190

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 43 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY

Affected (43 states)Not affected

About Ossur H / F

Ossur H / F has 29 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report