FDA-Device2024-03-13Class II

1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S

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
17 units
Manufactured in
1301 Goshen Pkwy, West Chester, PA, United States
Products
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1235-2024

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