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
This recall has been terminated (originally issued February 8, 2007).
- Recall Initiated
- December 18, 2006
- Posted
- February 8, 2007
- Terminated
- July 16, 2007
- Recall Number
- Z-0411-2007
- Quantity
- 58 units
- Firm Location
- Bartlett, TN
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide, including USA, the Netherlands, Canada, Australia, and the Bahamas.
Lot / Code Info
Lot numbers: MH05F006 and MH05J015
Root Cause
Other
Action Taken
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.