FDA Enforcement
Class II
Terminated
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
Recall: Z-0466-2016
·
Reported December 30, 2015
Enforcement
- Recall Number
- Z-0466-2016
- Event ID
- 72811
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Synvasive Technology Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 30, 2015
- Initiation Date
- December 8, 2015
- Classification Date
- December 22, 2015
- Termination Date
- November 1, 2016
- Address
- 4925 Robert J Mathews Pkwy, N/A, El Dorado Hills, CA, 95762-5701, United States
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
Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.
Code Info
Synvasive Part number: 11-4770; Part number: 19075127YT1; Lot numbers: 45104 and 43054.
Distribution
US Distribution to one location each in CT, MA and CA.
Quantity
14