Reported Dec 28, 2016 · Terminated

Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah…

Amendia, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Amendia, Inc · 1755 W Oak Pkwy · Marietta, GA · 30062-2260

13 of 13 products

Products covered by this recall
Model / number	Product as published
`10704-200`	Savannah-T Straight Rod, 200mm
`10704-250`	Savannah-T Straight Rod, 250mm
`10704-300`	Savannah T-Straight Rod 300mm
`10704-400`	Savannah-T Straight Rod, 400mm
—	Savannah-T Straight Rod, 500mm
—	Savannah-T High Top Straight Rod, 200mm
`1705-220`	Savannah-T High Top Straight Rod, 220mm
`10705-240`	Savannah-T High Top Straight Rod, 240mm
`10705-260`	Savannah-T Straight Rod, 260mm
`10705-280`	Savannah-T Straight Rod, 280mm
`10705-300`	Savannah-T Straight Rod, 300mm
`10706-200`	Savannah-T Notched Curved Rod, 200mm
`10707-200`	Savannah-T Curve Rod, 200mm, The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

The agency filed one notice per product. You are reading one of them; the other 6 are below.

The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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