FDA-Device2016-11-30Class II
3.0 mm Guide Rod/950 mm with Smooth Tip, 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
319 units
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0640-2017Don't want to check this manually?
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