Device product

Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766

Z-0938-2019

December 21, 2018

Class II

Product summary

Firm: Zimmer Biomet, Inc.
Event: Event 82004
Status: Terminated
Classification: Class II
Quantity: 90 units
Official record key: device-enforcement:Z-0938-2019

Official wording

Reason: Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.

Code information: Lot Number: 381800 UDI Number: (01)00880304434349(17)230301(10)381800 Lot NUmber: 400030 (01)00880304434349(17)230329(10)400030

Distribution pattern: MN, VA Foreign: Korea, New Zealand and Japan

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.