Device 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
Z-1676-2020
Product summary
- Event
- Event 85223
- Status
- Terminated
- Classification
- Class II
- Quantity
- 266 units
- Official record key
device-enforcement:Z-1676-2020
Official wording
Reason: Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
Code information: Lot Number/UDI: 265474 (01)00846795028320(17)220414(10)265474 304117 (01)00846795028320(17)230131(10)304117 317918 (01)00846795028320(17)230531(10)317918
Distribution pattern: US distribution to states of AL and NY
Derived failure modes
-
Labeling or packaging
Mislabeled