Recall Z-2445-2023 ยท ITJ Walker, Mechanical
Invacare Corporation
DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR
| Date | Aug 23, 2023 (initiated Jun 15, 2023) |
| Status | Open, Classified |
| Reason | Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user |
| Root cause | Device Design |
| Action | Invacare initiated on June 15, 2023 via electronic communications Urgent Medical Device Field Correction to consignees. Letter states reason for recall, health risk and action to take: 1. Review your existing stock to locate, quarantine, and return the affected devices to Invacare. A list of serial numbers is attached to assist in this process. An example product label for is shown below with annotations. 2. For affected Dolomite Gloss rollators already delivered to a customer, please contact the customer immediately to inform them that the Dolomite Gloss rollator(s) that they purchased is |
| Quantity | 586 devices |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.