Zimmer Biomet, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0111-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The device is a single use implant intended for implantation with bone cement.

Product Classification:

Class II

Date Initiated: August 9, 2016

Date Posted: October 26, 2016

Recall Number: Z-0111-2017

Event ID: 75237

Reason for Recall:

Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM Risks: Adverse health outcomes that could occur as a result of this event are a delay less than 30 minutes and a different size augment being used to complete the procedure. As the augment will not assemble with femoral component due to its shape, it would be easily identified during surgery.

Status: Terminated

Product Quantity: 5

Code Information:

Item Number 184108 Lot Number 183410 Exp. 8/27/2025

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of NJ, MI, FL and the countries of Sweden and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated