Z-0411-2007

Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea...

Name: Z-0411-2007 Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea...
Creator: Medtronic Sofamor Danek Instrument Manufacturing
Published: 2006-12-18
License: https://open.fda.gov/license/

Medtronic Sofamor Danek Instrument Manufacturing / initiated 2006-12-18 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek Instrument Manufacturing began a recall of 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... on 2006-12-18. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0411-2007
Status: Terminated
Initiated: 2006-12-18
Posted: 2007-02-08
Terminated: 2007-07-16
Recalling firm: Medtronic Sofamor Danek Instrument Manufacturing
Product: 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
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm sent out the recall letter via Federal Express to direct consignees on 12/18/2006. The letter explained the problem, requested discontinuation of use and stated that sales representatives would be coordinating the retrieval and replacement of the device.
Quantity in commerce: 58 units
Distribution: Worldwide, including USA, the Netherlands, Canada, Australia, and the Bahamas.
Product codes and lots: Lot numbers: MH05F006 and MH05J015

Product code MNI

K042210Class IIMsd Silo Spinal SystemMedtronic Sofamor Danek / cleared 2004-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)