Z-1992-2013Class II

Stryker Visum 300 Ceiling-mounted Exam Light

Name: Z-1992-2013 Stryker Visum 300 Ceiling-mounted Exam Light
Creator: Stryker Communications
Published: 2013-07-25
License: https://open.fda.gov/license/

STRYKER Communications, Inc. / initiated 2013-07-25 / Terminated / root cause: manufacturing process

FDA source

Stryker Communications began a recall of Stryker Visum 300 Ceiling-mounted Exam Light on 2013-07-25. FDA classified it as Class II and gives the reason as "Potential incomplete final weld on the drop tube flange". 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-1992-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-25
Posted: 2013-08-21
Terminated: 2015-04-03
Recalling firm: STRYKER Communications, Inc.
Product: Stryker Visum 300 Ceiling-mounted Exam Light.
Product code: KZF Device, Medical Examination, Ac Powered
Reason for recall: Potential incomplete final weld on the drop tube flange.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm decided to recall and notified consignees with an "Urgent Medical Device Correction/Removal" notification letter dated 07/29/13. The product issue was described and recommended actions were provided. Customers may contact Stryker Technical Support at 866-841-5663.
Quantity in commerce: 1,375 units
Distribution: Worldwide Distribution: US natiowide and to the country of Canada.
Product codes and lots: Product sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1992-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1992-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-21

Product code KZF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)