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

FDA device recall Z-2199-2008 · posted 2008-09-16 · Terminated

Recall details

Recalling firm

Biomet 3i, Inc.

Reason for recall

The drill malfunctions while in use. The drill has been observed to become lodged in the handle.

Action taken

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

Status

Terminated

Product code

EJB

Distribution

Worldwide.

Date initiated

2008-05-09

Date posted

2008-09-16

Date terminated

2009-01-15

Location

Palm Beach Gardens, FL