Recall Z-0231-2024 ยท ITJ Walker, Mechanical
Breg Inc
BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
| Date | Nov 3, 2023 (initiated Sep 13, 2023) |
| Status | Open, Classified |
| Reason | Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels. |
| Root cause | Process design |
| Action | 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.