Z-1167-2014Class II

Navigator Surgical Kit

Name: Z-1167-2014 Navigator Surgical Kit
Creator: Biomet 3i, LLC
Published: 2013-07-22
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2013-07-22 / Terminated / root cause: sterility

FDA source

Biomet 3i, LLC began a recall of Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing on 2013-07-22. FDA classified it as Class II and gives the reason as "During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1167-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-22
Posted: 2014-03-12
Terminated: 2015-04-21
Recalling firm: ZimVie US Corp LLC
Product: Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Product code: LRO General Surgery Tray
Reason for recall: During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Root cause tag: sterility
FDA root cause: Unknown/Undetermined by firm
Action: Biomet 3i sent an Urgent Medical Device Field Correction Notice dated July 2013 to all affected customer via email, facsimile, or postal mail. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to complete the attached response form and fax to 561-514-6316. For questions contact Biomet 3i customer service at 1-800-342-5454.
Quantity in commerce: 21
Distribution: Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.
Product codes and lots: SGKIT (SGTRAY)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1167-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1167-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-11
Z-1168-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-11
Z-1169-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-11
Z-1170-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-11
Z-1171-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-11

Product code LRO

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)