Recall Z-1676-2020— Synvasive Technology Inc
Class II · Terminated
Class II FDA medical device recall by Synvasive Technology Inc, initiated 2018-07-27, terminated 2021-06-07. FDA's recall record names no specific 510(k) clearance for this event. Product: ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer. Reason: Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm..
- Recalling firm
- Synvasive Technology Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-27
- Terminated
- 2021-06-07
- Firm location
- El Dorado Hills, CA, United States
Product description
ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer
Reason for recall
Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
Data sourced from openFDA. This site is unofficial and independent of the FDA.