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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Medtronic Sofamor Danek Instrument Manufacturing
Lot Codes / Batch Numbers
Lot numbers: MH05F006 and MH05J015
Products Sold
Lot numbers: MH05F006 and MH05J015
Medtronic Sofamor Danek Instrument Manufacturing is recalling Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qt due to Due to a manufacturing error, the proximal end may deform causing the protrusions that engage the associated implant to break off of the instrument du. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026