Biomet, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1798-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.

Product Classification:

Class II

Date Initiated: April 22, 2015

Date Posted: June 24, 2015

Recall Number: Z-1798-2015

Event ID: 71253

Reason for Recall:

The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the keel marked LM and the L on the same side as the keel marked RM. This is incorrect. Please note that the keel is not etched on this side by design.

Status: Terminated

Product Quantity: 27

Code Information:

Part 32-423101 Lot 414930 Part 32-423102 Lot 116490 Part 32-423106 Lot 785220 Part 32-423107 Lot 873780 Part 32-423108 Lot 070420 and 785250 Part 32-423109 Lot 670630 Part 32-423115 Lot 672920 Part 32-423119 Lot 785290 Part 32-423116 Lot 073640 Part 32-423101 Lot 785170 Part 32-423102 Lot 785180 Part 32-423109 Lot 785260 Part 32-423124 Lot 024760 Part 32-423110 Lot 785270

Distribution Pattern:

Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile.

Voluntary or Mandated:

Voluntary: Firm initiated