FDA-Device2013-09-04Class II
Synthes Trauma Nail System. The devices are indication for bone fixation.
Synthes USA HQ, Inc.
Hazard
Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.
Sold states
Nationwide distribution.
Affected count
1,011,783
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
Synthes Trauma Nail System. The devices are indication for bone fixation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2058-2013Don't want to check this manually?
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