Device product
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
Z-0466-2016
Product summary
- Event
- Event 72811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14
- Official record key
device-enforcement:Z-0466-2016
Official wording
Reason: Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.
Code information: Synvasive Part number: 11-4770; Part number: 19075127YT1; Lot numbers: 45104 and 43054.
Distribution pattern: US Distribution to one location each in CT, MA and CA.
Derived failure modes
-
Unknown
Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.