FDA Enforcement
Class II
Terminated
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
Recall: Z-1676-2020
·
Reported April 15, 2020
Enforcement
- Recall Number
- Z-1676-2020
- Event ID
- 85223
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Synvasive Technology Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 15, 2020
- Initiation Date
- July 27, 2018
- Classification Date
- April 6, 2020
- Termination Date
- June 7, 2021
- Address
- 4925 Robert J Mathews Pkwy, N/A, El Dorado Hills, CA, 95762-5701, United States
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
Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
Code Info
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
US distribution to states of AL and NY
Quantity
266 units