Recall Z-1594-2021
WillowWood Global Llc · initiated April 20, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot: 'xx' stamped on the outside of the Lanyard body manufactured form 04/01/2020 - 04/08/2021
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: Process change control
Action taken
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.
Details
- Recall number
- Z-1594-2021
- Initiated
- April 20, 2021
- Product code
- IPM – Cover, Limb
- Quantity
- 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
- Recalling firm
- WillowWood Global Llc, Mount Sterling, OH