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Terminated

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).

FDA Recall Z-0050-2007 · Posted 2006-10-19

Recalling FirmMedtronic Sofamor Danek Instrument Manufacturing
Recall StatusTerminated
Product CodeHTO
Date Initiated2006-08-01
Date Terminated2007-04-04
Product Quantity9 units

Reason for Recall

Bone reamer may not have a cutting surface on the tip.

Firm Action

The firm notified its hospital consignees by letter dated 08/01/2006. The letter requested cessation of use and return.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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