FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek Instrument Manufacturing: 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
- Recall number
- Z-0411-2007
- 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
- Status
- Terminated
- Initiated
- 2006-12-18
- Posted
- 2007-02-08
- Terminated
- 2007-07-16
- Reason
- 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
- 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
- 58 units
- Distribution
- Worldwide, including USA, the Netherlands, Canada, Australia, and the Bahamas.
- Lot, serial or model codes
- Lot numbers: MH05F006 and MH05J015
- 510(k) numbers
- ["K042210"]
- PMA numbers
- not on file
- Product code
- MNI
- Firm FEI
- 3004564008
- Firm city
- Bartlett
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28