FDA-Device2024-03-13Class II
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
Synthes (USA) Products LLC
Hazard
Products not sterilized, sterility cannot be confirmed
Sold states
Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
Affected count
5 units
Manufactured in
1301 Goshen Pkwy, West Chester, PA, United States
Products
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1234-2024Don't want to check this manually?
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