Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1958-2011

Dental chairs distributed under several brand names such as DCI Equipment; Marus MaxStar; Marus NuStar; and...

DCI International, LLC / initiated 2011-03-01 / Terminated / root cause: manufacturing process

Dental Equipment LLC began a recall of Dental chairs distributed under several brand names such as DCI Equipment; Marus MaxStar; Marus NuStar; and Pelton & Crane. Part number for the bolt: 022R065... on . The reason FDA records is "Link arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1958-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
DCI International, LLC
Product
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.
Product code
NRU Chair, Dental, Without Operative Unit
Reason for recall
Link arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair.
Root cause tag
manufacturing process
FDA 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 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.
Quantity in commerce
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.
Product codes and lots
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.