Recall Z-1594-2021— WillowWood Global Llc

Class II FDA medical device recall by WillowWood Global Llc, initiated 2021-04-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..

Recalling firm

WillowWood Global Llc

Classification

Class II

Status

Ongoing

Initiated

2021-04-20

Firm location

Mount Sterling, OH, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.