FDA-Device2018-03-14Class II
3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Synthes (USA) Products LLC
Hazard
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Sold states
Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.
Affected count
960
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0904-2018Don't want to check this manually?
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