Victory 10, 4 Wheel (SC710) Mobility medical device

FDA device recall Z-3212-2011 · posted 2011-09-14 · Terminated

Recall details

Recalling firm

Pride Mobility Products Corp

Reason for recall

Contract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings.

Action taken

Pride Mobility Products Corp. sent a "RECALL OF VICTORY 3 AND 4 WHEEL UNITS; REPLACEMENT OF FUSES" letter dated June 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers are asked in the letter to locate their affected Victory unit(s) and inform users of the recall. A letter has been provided by the firm to distribute to users alerting them to the recall. Additionally, customers are to set up an appointment with users to replace the fuses. Customers are instructed to contact Pride's Upgrade department at 866-222-6212 to order the kit and for questions regarding this recall. .

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

INI

Distribution

Worldwide Distribution-USA (nationwide) including the District of Columbia and Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN,

Date initiated

2011-06-22

Date posted

2011-09-14

Date terminated

2014-11-20

Location

Exeter, PA

Related 510(k) clearances