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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.
Brand
Biomet 3i, Inc.
Lot Codes / Batch Numbers
Kit Lots# 790554, 790555, 807340, 799305, 807340, 790082, and 808640.
Products Sold
Kit Lots# 790554, 790555, 807340, 799305, 807340, 790082, and 808640.
Biomet 3i, Inc. is recalling Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. due to The drill malfunctions while in use. The drill has been observed to become lodged in the handle.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The drill malfunctions while in use. The drill has been observed to become lodged in the handle.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026