Recall Z-1958-2011 ยท NRU Chair, Dental, Without Operative Unit
Dental Equipment LLC
Dental chairs distributed under several brand names such as DCI Equipment; Marus MaxStar; Marus NuStar; and Pelton & Crane. Part number for the bolt: 022R065 Product is labeled in part: DCI Equipment, Mfg By: Dental Equipment, LLC. DC1235, Marus Dental, Mfg By: Dental Equipment, LLC. DC1490, DC1690, and DC1700, and DC1702, Pelton & Crane, Spirit SP17.
| Date | Apr 12, 2011 (initiated Mar 1, 2011) |
| Status | Terminated |
| Reason | Link arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair. |
| Root cause | Process control |
| Action | On 03/08/11, Dental Equipment LLC. started sending out the Medical Device Recall notification letter via USPS 1st class mail to US consignees and Federal Express mail to foreign consignees. The firm also sent a recall notification letter to consignees who only purchased dental accessories such as Rear Mounted Cuspidor with Coverset, Arm Articulating Rear Mounted Cuspidor - Marus Gray, Maxstar Orbit Cuspidor utility W/ Porcelain bowl, and zinc plated bolts. The letter identified the affected dental chair as Marus brand with the following model numbers: DC1490, DC1690, DC1700 and DC1702. The |
| Quantity | 55 chairs and 11 replacement bolts distributed to US and foreign consignees outside the US. |
| Distribution | Worldwide distribution to USA, Australia, Canada, Ireland, South Africa, and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.