Recall Z-0466-2016— Synvasive Technology Inc
Class II · Terminated
Class II FDA medical device recall by Synvasive Technology Inc, initiated 2015-12-08, terminated 2016-11-01. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm..
- Recalling firm
- Synvasive Technology Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-08
- Terminated
- 2016-11-01
- Firm location
- El Dorado Hills, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.