Z-2455-2012Class II

REF LS7600Qty 1* EC REP* ConMed Linvatec Xenon Light Source

Name: Z-2455-2012 ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2011-05-20
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2011-05-20 / Terminated / root cause: manufacturing process

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source on 2011-05-20. FDA classified it as Class II and gives the reason as "Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide...". 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-2455-2012
Classification: Class II
Status: Terminated
Initiated: 2011-05-20
Posted: 2012-09-25
Terminated: 2012-09-26
Recalling firm: Linvatec Corporation
Product: ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
Product code: GCT Light Source, Endoscope, Xenon Arc
Reason for recall: Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Linvatec Corporation sent an "URGENT Medical Device Recall Notification letter dated May 20, 2011 to its customers via FedEx service. Firm advised their suppliers of the Light Sources potentially has unapproved components and does not meet the finished product requirement. The distributors and end user level are advised if any affected product is in their possession can be used until returned for advance exchange. The customers were instructed to: 1) locate the identified product by serial number at your facility and complete the Reply Form attached; 2) Contact ConMed Linvatec Customer Service (800-237-0169) to receive SR Number Advance Exchange affected product only. Once Customer Service authorizes the SR Number your Advance Exchange Light Source will be shipped to your facility; 3) Once replacement unit is received, utilize the packaging material to return the recalled Light Source to ConMed Linvatec using the enclosed FedEx Airway Bill. Mail or FAX copy of Reply Form to ConMed Linvatec; 4) Complete and return a copy of the Reply Form. For questions contact your local ConMed Linvatec office or email [email protected], Customer Service at 800-237-0169 or fax to 727-319-5701.
Quantity in commerce: 1
Distribution: Worldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA.
Product codes and lots: GCT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2455-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2455-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-25
Z-2456-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-25

Product code GCT

K070376Class IIConmed Linvatec 300W Xenon Light SourceConmed Linvatec / cleared 2007-08-20

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)