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

FDA device recall Z-1958-2011 · posted 2011-04-12 · Terminated

Recall details

Recalling firm

Dental Equipment LLC

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.

Action taken

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

Status

Terminated

Product code

NRU

Quantity affected

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.

Date initiated

2011-03-01

Date posted

2011-04-12

Date terminated

2011-09-21

Location

Newberg, OR