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U.S. Department of Health and Human Services

Class 2 Device Recall DCI Equipment; Marus MaxStar; Marus NuStar; Pelton & Crane Spirit

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 Class 2 Device Recall DCI Equipment; Marus MaxStar; Marus NuStar; Pelton & Crane Spiritsee related information
Date Initiated by FirmMarch 01, 2011
Date PostedApril 12, 2011
Recall Status1 Terminated 3 on September 21, 2011
Recall NumberZ-1958-2011
Recall Event ID 58122
Product Classification dental chair - Product Code NRU
ProductDental 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.
Code Information 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.   
FEI Number 1000523896
Recalling Firm/
Manufacturer		 Dental Equipment LLC
705 S Springbrook Rd Bldg B200
Newberg OR 97132-7057
For Additional Information ContactBonnie Dundas
503-537-3619
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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 Commerce55 chairs and 11 replacement bolts distributed to US and foreign consignees outside the US.
DistributionWorldwide distribution to USA, Australia, Canada, Ireland, South Africa, and Vietnam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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