BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.

FDA device recall Z-0231-2024 · posted 2023-11-03 · Open, Classified

Recall details

Recalling firm

Breg Inc

Reason for recall

Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.

Action taken

On 09/13/2023, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx to customer informing them that folding walkers distributed between June 2023 to August 2023 did not meet product specifications for wheel alignment. Products exhibit: -Misalignment of wheels may result in immobility of walker -Misalignment of wheels may result in obstruction of glide/roll Customers are instructed to: -Immediately examine their inventory and quarantine products subject to this recall -For devices separated from labeling, visual examination of devices may be required. The misalignment looks like the wheels are not parallel to each other. -Segregate product with misaligned wheels and return to Breg via Return Material Authorization (RMA or Return Inventory (RI) process. -Review and fill out the response form and return to Breg. For questions, email to bregfieldcorrection@breg.com

Root cause

Process design

Status

Open, Classified

Product code

ITJ

Quantity affected

11,193 units

Distribution

U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY. O.U.S.: N/A

Date initiated

2023-09-13

Date posted

2023-11-03

Location

Carlsbad, CA