Z-0723-2021 Class II Terminated
FDA device recall Z-0723-2021 was initiated by Biomet, Inc. on December 1, 2020 and is designated Class II. Reason for recall: Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure The recall status is terminated (terminated July 8, 2022). Affected quantity: 21 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- December 1, 2020
- Termination Date
- July 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units
Product Description
Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
Reason for Recall
Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, Japan, Netherlands.
Code Information
Lot Number: 098780 UDI Number: (01) 00880304482739 (17) 290501 (10) 098780