Medtronic Sofamor Danek Instrument Manufacturing Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/clinic). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/clinic).
Brand
Medtronic Sofamor Danek Instrument Manufacturing
Lot Codes / Batch Numbers
Lot Nos.: CN04J012, CN06A003
Products Sold
Lot Nos.: CN04J012, CN06A003
Medtronic Sofamor Danek Instrument Manufacturing is recalling Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tenne due to Bone reamer may not have a cutting surface on the tip.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Bone reamer may not have a cutting surface on the tip.
Recommended Action
Per FDA guidance
The firm notified its hospital consignees by letter dated 08/01/2006. The letter requested cessation of use and return.
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