WillowWood Global Llc recalls Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with…

Recall date

April 20, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1594-2021

FDA classification

Class II

Brand / firm

WillowWood Global Llc

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, KS, KY, LA, MA, ME, MN, MO, MS, NJ, NM, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and the countries of Germany, Netherlands

Why it was recalled

the firm discovered that, starting on April 1, 2020, a 3/8 dowel pin was used in place of the 5/8 pin. Over time, the shorter pin may not engage in either the upper or lower body, causing the cord to come loose or slip which could result in the loss of suspension.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve plus a locking mechanism. Product design features an easy release mechanism. Available with or without a titanium pyramid. The lanyard is part of the Alpha Interlock" Suspension System. This system allows you to interchange suspension methods without remaking a socket Model, 3 part numbers - 700-AIS100, Alpha Interlock Suspension System with Alpha Lanyard - 700-AIS101, Alpha Interlock Suspension System with Alpha Lanyard w/Titanium Pyramid - 700-AIS107, Alpha Interlock Suspension System Lanyard Body ONLY