FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2199-2008
- Recalling firm
- Biomet 3i, Inc.
- Product
- Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.
- Status
- Terminated
- Initiated
- 2008-05-09
- Posted
- 2008-09-16
- Terminated
- 2009-01-15
- 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 Biomet 3I. Replacement handles will be provided. Contact Biomet 3i, at 1-561-776-6906 or x6904 for assistance.
- Quantity
- not on file
- Distribution
- Worldwide.
- Lot, serial or model codes
- Kit Lots# 790554, 790555, 807340, 799305, 807340, 790082, and 808640.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EJB
- Firm FEI
- 1038806
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28