RegWardenFDA facility compliance records
Recall

Class II — WillowWood Global Llc

Recalling firmWillowWood Global LLC
Registered facilityView this company's 3 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
Reasonthe 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.
ProductAlpha 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 - 7…
Quantity815 parts
DistributionWorldwide 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
Initiated2021-04-20
Classified2021-05-14
Recall numberZ-1594-2021
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — WillowWood Global Llc (Z-1594-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87825/

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