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Terminated

Pelton & Crane Spirit 3000 dental chair (Model #SP30)

FDA Recall Z-1850-2011 · Posted 2011-03-30

Recalling FirmPelton & Crane Company
Recall StatusTerminated
Product CodeNRU
Date Initiated2011-03-04
Date Terminated2011-08-16
Product Quantity9 units

Reason for Recall

The Link Arm Assembly that connects some rear mounted options to the Spirit 3000 or Spirit 1800 dental chairs may potentially break and fall off the dental chair.

Firm Action

Pelton & Crane sent an "Urgent Medical Device Recall" letter dated 3/04/2011. They were instructed to: Locate the affected devices this recall is in regards to. Schedule service with the end user for Pelton & Crane representative to replace the affected components this recall is in regards to. International accounts were instructed to order link arm assemblies from Pelton & Crane and replace the affected components. All consignees were to complete the Recall Acknowledgement/Return Form and return the form to Pelton & Crane.

Root Cause

Process control

Distribution Pattern

Distribution to USA, Canada, and the Netherlands.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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