Z-0466-2016 Class II Terminated
FDA device recall Z-0466-2016 was initiated by Synvasive Technology Inc on December 8, 2015 and is designated Class II. Reason for recall: Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm. The recall status is terminated (terminated November 1, 2016). Affected quantity: 14.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2015
- Initiation Date
- December 8, 2015
- Termination Date
- November 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
Product Description
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
Reason for Recall
Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.
Distribution Pattern
US Distribution to one location each in CT, MA and CA.
Code Information
Synvasive Part number: 11-4770; Part number: 19075127YT1; Lot numbers: 45104 and 43054.