Device product
Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
Z-0723-2021
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 86923
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21 units
- Official record key
device-enforcement:Z-0723-2021
Official wording
Reason: Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
Code information: Lot Number: 098780 UDI Number: (01) 00880304482739 (17) 290501 (10) 098780
Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, Japan, Netherlands.
Derived failure modes
-
Unknown
Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure