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U.S. Department of Health and Human Services

Class 2 Device Recall Alpha Interlock Suspension System Lanyard Body

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 Class 2 Device Recall Alpha Interlock Suspension System Lanyard Bodysee related information
Date Initiated by FirmApril 20, 2021
Create DateMay 14, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1594-2021
Recall Event ID 87825
Product Classification Cover, limb - Product Code IPM
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 - 700-AIS107, Alpha Interlock Suspension System Lanyard Body ONLY
Code Information Lot: 'xx' stamped on the outside of the Lanyard body manufactured form 04/01/2020 - 04/08/2021
FEI Number 1522166
Recalling Firm/
Manufacturer		 WillowWood Global Llc
15441 Scioto Darby Rd
Mount Sterling OH 43143-9036
For Additional Information ContactSteve Huggins
740-869-3377 Ext. 200
Manufacturer 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 Determined
Cause 2		Process change control
ActionOn 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 Commerce815 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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