FDA-Device2015-12-30Class II
Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 and 43054 Description: STRYK_76542K_19X75X1.27T General and Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures
Synvasive Technology Inc
Hazard
Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.
Sold states
US Distribution to one location each in CT, MA and CA.
Affected count
14
Manufactured in
4925 Robert J Mathews Pkwy, N/A, El Dorado Hills, CA, United States
Products
Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 and 43054 Description: STRYK_76542K_19X75X1.27T General and Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0466-2016Don't want to check this manually?
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