Recall Z-2199-2008 ยท EJB Handle, Instrument, Dental
Biomet 3i, Inc.
Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.
| Date | Sep 16, 2008 (initiated May 9, 2008) |
| Status | Terminated |
| Reason | The drill malfunctions while in use. The drill has been observed to become lodged in the handle. |
| 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 Biome |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.