Z-2199-2008

Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The...

Name: Z-2199-2008 Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The...
Creator: Biomet 3i, Inc.
Published: 2008-05-09
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2008-05-09 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, Inc. began a recall of Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery on 2008-05-09. The reason FDA records is "The drill malfunctions while in use. The drill has been observed to become lodged in the handle". 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-2199-2008
Status: Terminated
Initiated: 2008-05-09
Posted: 2008-09-16
Terminated: 2009-01-15
Recalling firm: ZimVie US Corp LLC
Product: Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.
Product code: EJB Handle, Instrument, Dental
Reason for recall: The drill malfunctions while in use. The drill has been observed to become lodged in the handle.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recall was initiated in 5/9/2008. Each US customer was contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i performed a follow-up of each call with a fax letter. International customers were first contacted by E-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affect product to Biomet 3I. Replacement handles will be provided. Contact Biomet 3i, at 1-561-776-6906 or x6904 for assistance.
Distribution: Worldwide.
Product codes and lots: Kit Lots# 790554, 790555, 807340, 799305, 807340, 790082, and 808640.

Product code EJB

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)