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.
FDA Recall Z-1958-2011 · Posted 2011-04-12
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Recalling FirmDental Equipment LLC
Recall StatusTerminated
Product CodeNRU
Date Initiated2011-03-01
Date Terminated2011-09-21
Product Quantity55 chairs and 11 replacement bolts distributed to US and foreign consignees outside the US.
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide distribution to USA, Australia, Canada, Ireland, South Africa, and Vietnam.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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