FDA-Device2016-11-30Class II
2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
Synthes (USA) Products LLC
Hazard
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Sold states
Distributed Nationwide
Affected count
1,951 units
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0637-2017Don't want to check this manually?
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