FDA Device

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.

Hazard

Link arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair.

What You Should Do

Remedy

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 firm's corrective action including the replacement of the affected link arm assembly with a new link arm assembly. The firm's field representative will contact each consignee for an appointment to replace the affected link arm assembly. Consignees can contact the Dental Equipment LLC at 503-537-3617 for any questions.

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Products

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 Equipme
Brand
Dental Equipment LLC
UPC
Part number for the bolt: 022R065  Chair Serial Numbers: 1961, 2127, 2260, 239446, 239446, 240619, 241535, 242384, 242711, 242862, 244489, 244502, 244530, 244977, 245874, 246275, 246526, 247557, 247813, 247976, 248040, 248871, 249015, 249235, 249238, 249441, 249784, 218756C, 2250, 2251, 240126, 240126A , 240605, 240605A, 240605B, 240605C, 240605D, 240605E, 241379, 241379A, 241379B, 242154J, 242154K, 242154L, 245767, 245767F, 246769, 246769A , 247199AE, 247199AJ, 248129F, 248321, 248321A, 248378C, 248824, and 248824A.

Units Affected

55 chairs and 11 replacement bolts distributed to US and foreign consignees outside the US.

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