Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-3249-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty

Product Classification:

Class II

Date Initiated: August 2, 2018

Date Posted: October 3, 2018

Recall Number: Z-3249-2018

Event ID: 80904

Reason for Recall:

The implant only has one bolt in the sterile package but it should have had two.

Status: Terminated

Product Quantity: 16

Code Information:

Lot 320390, UDI (01) 0088030448157 (17) 230129 (10) 320390

Distribution Pattern:

Worldwide Distribution: US (nationwide) to the following US states: AZ, KS, NM, NV, and UT; and to countries of: Australia and Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated