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Terminated

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

FDA Recall Z-0411-2007 · Posted 2007-02-08

Recalling FirmMedtronic Sofamor Danek Instrument Manufacturing
Recall StatusTerminated
Product CodeMNI
Date Initiated2006-12-18
Date Terminated2007-07-16
Product Quantity58 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, the Netherlands, Canada, Australia, and the Bahamas.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042210MSD SILO SPINAL SYSTEMMedtronic Sofamor Danek · 2004-11-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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