Z-1594-2021Class II

Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes...

Name: Z-1594-2021 Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes...
Creator: WillowWood Global Llc
Published: 2021-04-20
License: https://open.fda.gov/license/

WillowWood Global LLC / initiated 2021-04-20 / Open, Classified

FDA source

WillowWood Global Llc began a recall of Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve plus a... on 2021-04-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1594-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-20
Posted: 2021-05-14
Recalling firm: WillowWood Global LLC
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
Product code: IPM Cover, Limb
Reason for recall: 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.
FDA root cause: Process change control
Action: On 04/20/2021, Willow Wood issued an Urgent Medical Device Removal notice to customer via letter notifying them it was 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.
Quantity in commerce: 815 parts
Distribution: 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
Product codes and lots: Lot: 'xx' stamped on the outside of the Lanyard body manufactured form 04/01/2020 - 04/08/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1594-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1594-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-14

Product code IPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)