Z-1177-2012

Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte...

Name: Z-1177-2012 Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte...
Creator: Pelton & Crane Company
Published: 2012-02-20
License: https://open.fda.gov/license/

KaVo Dental Technologies, LLC / initiated 2012-02-20 / Terminated / root cause: manufacturing process

FDA source

Pelton & Crane Company began a recall of Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte, NC 28273 Product Usage: The intended use of the... on 2012-02-20. The reason FDA records is "Modification of the Pelton & Crane Spirit 3000 unit disabled the TLC SAFEdrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating up". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1177-2012
Status: Terminated
Initiated: 2012-02-20
Posted: 2012-03-06
Terminated: 2012-03-28
Recalling firm: KaVo Dental Technologies, LLC
Product: Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte, NC 28273 Product Usage: The intended use of the dental operative unit is for supplying power and to serve as a base for other dental devices, such as a dental hand piece, air/water syringe, oral cavity evacuator, a suction operative unit, and other dental devices. The TLC SAFEdrive option is an optional feature that monitors the operation of the high speed hand piece and gives an audible and visual signal to let the user know if the hand piece is potentially damaged or heating up.
Product code: EIA Unit, Operative Dental
Reason for recall: Modification of the Pelton & Crane Spirit 3000 unit disabled the TLC SAFEdrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating up.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Pelton & Crane sent an Urgent Medical Device Recall letter dated February 20, 2012 to all affected customers. The letter identifies the affected product, problem and actions to be taken. The letter states that a Pelton & Crane representative will be contacting the customers to schedule a service appointment with the end user of the device so that the affected TLC SAFEdrive circuit board can be replaced and returned to Pelton & Crane. Customers were instructed to complete the attached Recall Acknowledgement/Return Form and fax it to Pelton & Crane, attention Frank Ray, at (704) 587-7250. The letter also requested customers to mail the original Recall Acknowledgement/Return Form in the enclosed self addressed stamped envelope.
Quantity in commerce: 2 units
Distribution: (USA) Nationwide Distribution
Product codes and lots: Model #SET30, Catalog #3120, Serial numbers 4096 and 4099.

Product code EIA

K946187Class ISpirit II and Spirit Treatment CenterPelton & Crane Co. / cleared 1995-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)