Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.
FDA Recall Z-2199-2008 · Posted 2008-09-16
Recalling FirmBiomet 3i, Inc.
Recall StatusTerminated
Product CodeEJB
Date Initiated2008-05-09
Date Terminated2009-01-15
Reason for Recall
The drill malfunctions while in use. The drill has been observed to become lodged in the handle.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.