Z-1101-2007

Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount)...

Name: Z-1101-2007 Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount)...
Creator: Sunnex Inc.
Published: 2007-02-13
License: https://open.fda.gov/license/

Sunnex, Inc. / initiated 2007-02-13 / Terminated

FDA source

Sunnex Inc. began a recall of Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount) , TS2015M (mobile) , TS2015W (wall mount)... on 2007-02-13. The reason FDA records is "Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1101-2007
Status: Terminated
Initiated: 2007-02-13
Posted: 2007-07-24
Terminated: 2009-01-06
Recalling firm: Sunnex, Inc.
Product: Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount) , TS2015M (mobile) , TS2015W (wall mount) , TS2035M (mobile)
Product code: FTA Light, Surgical, Accessories
Reason for recall: Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.
FDA root cause: Other
Action: Sunnex notifiied distributors by letter March 9, 2007. Sunnex is providing replacement product to end users
Quantity in commerce: 30 lamps
Distribution: Nationwide
Product codes and lots: Units manufactured between May 15, 2006 through October 1, 2006

Product code FTA

K930711Class IITri*starLight Technology Systems / cleared 1993-07-30

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)