Medtronic Sofamor Danek Instrument Manufacturing
Bartlett, TN
Medtronic Sofamor Danek Instrument Manufacturing appears in FDA device records in Bartlett, TN. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 39 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 39
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
Showing 25 of 39| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0411-2007 | Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile, Medtronic Sofamor Danek, 1800 Pyramid Place Memphis, TN 38132, USA, Manufactured at: Bartlett, Tennessee, USA | Due to a manufacturing error, the proximal end may deform causing the protrusions that engage the associated implant to break off of the instrument during use. | Terminated | ||
| Z-0050-2007 | 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). | Bone reamer may not have a cutting surface on the tip. | Terminated | ||
| Z-0753-06 | METRx II Tube, 22mm x 9cm stainless steel tubular retractor, Part No. 9569736 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0752-06 | METRx II Tube, 22mm x 8cm stainless steel tubular retractor, Part No. 9569735 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0751-06 | METRx II Tube, 22mm x 7cm stainless steel tubular retractor, Part No. 9569734 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0750-06 | METRx II Tube, 22mm x 6cm stainless steel tubular retractor, Part No. 9569733 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0749-06 | METRx II Tube, 22mm x 5cm stainless steel tubular retractor, Part No. 9569732 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0748-06 | METRx II Tube, 22mm x 4cm stainless steel tubular retractor, Part No. 9569731 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0747-06 | METRx II Tube, 22mm x 3cm stainless steel tubular retractor, Part No. 9569730 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0746-06 | METRx II Tube, 20mm x 9cm stainless steel tubular retractor, Part No. 9569726 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0745-06 | METRx II Tube, 20mm x 8cm stainless steel tubular retractor, Part No. 9569725 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0744-06 | METRx II Tube, 20mm x 7cm stainless steel tubular retractor, Part No. 9569724 | due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0743-06 | METRx II Tube, 20mm x 6cm stainless steel tubular retractor, Part No. 9569723 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0742-06 | METRx II Tube, 20mm x 5cm stainless steel tubular retractor, Part No. 9569722 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0741-06 | METRx II Tube, 20mm x 4cm stainless steel tubular retractor, Part No. 9569721 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0740-06 | METRx II Tube, 20mm x 3cm stainless steel tubular retractor, Part No. 9569720 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0739-06 | METRx II Tube, 18mm x 9cm stainless steel tubular retractor, Part No. 9569686 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0738-06 | METRx II Tube, 18mm x 8cm stainless steel tubular retractor, Part No. 9569685 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0737-06 | METRx II Tube, 18mm x 7cm stainless steel tubular retractor, Part No. 9569684 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0736-06 | METRx II Tube, 18mm x 6cm stainless steel tubular retractor, Part No. 9569683 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0735-06 | METRx II Tube, 18mm x 5cm stainless steel tubular retractor, Part No. 9569682 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0734-06 | METRx II Tube, 18mm x 4cm stainless steel tubular retractor, Part No. 9569681 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0733-06 | METRx II Tube, 18mm x 3cm stainless steel tubular retractor, Part No. 9569680 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0732-06 | METRx II Tube, 16mm x 9cm stainless steel tubular retractor, Part No. 9569676 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated | ||
| Z-0731-06 | METRx II Tube, 16mm x 8cm stainless steel tubular retractor, Part No. 9569675 | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain