Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA, Rx only. Th
FDA device recall Z-0050-2007 · posted 2006-10-19 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek Instrument Manufacturing
- Reason for recall
- Bone reamer may not have a cutting surface on the tip.
- Action taken
- The firm notified its hospital consignees by letter dated 08/01/2006. The letter requested cessation of use and return.
- Root cause
- Other
- Status
- Terminated
- Product code
- HTO
- Quantity affected
- 9 units
- Distribution
- Nationwide
- Date initiated
- 2006-08-01
- Date posted
- 2006-10-19
- Date terminated
- 2007-04-04
- Location
- Bartlett, TN
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