Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2289-2018)

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 Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.

Product Classification:

Class II

Date Initiated: May 24, 2018

Date Posted: July 4, 2018

Recall Number: Z-2289-2018

Event ID: 80186

Reason for Recall:

Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.

Status: Terminated

Product Quantity: 48

Code Information:

Lots 198810 and 210320

Distribution Pattern:

Distributed to accounts in CA, CT, GA, IA, IN, LA, MA, MD, MN, MS, NJ, OH, PA, TN, TX, UT, VA, WI. Foreign distribution to Taiwan, Japan, and the Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated