FDA-Device2016-11-30Class II
2.5 mm Reaming Rod W/Ball Tip 650 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
2,157 units
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0644-2017Don't want to check this manually?
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