IPMClass I

Cover, Limb

Physical Medicine · 21 CFR 890.3025

MDR events6All time

Recalls1All time

Registered firms151Currently listed

510(k) clearances6All time

Recent MDR events

6 adverse event reports on file

Event type breakdown

Injury3

Malfunction3

Most-reported manufacturers

Unspecified1 3m Health Care1 Medichoice / Owens & Minor1 Ohio Willow Wood1 Ortho And Surgical Products Enterprises S.a.1 Ortho Care Casting, Llc1 Wright & Filippis Inc1

Recalls

1 recall events for this product code

WillowWood Global Llc
Open, ClassifiedUnknown
Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve plus a lock
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.
Z-1594-2021 · View FDA record ↗

Registered firms

151 firms currently registered for this product code

510(k) clearances

6 clearances for this product code