Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0980-2018)

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:

Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty

Product Classification:

Class II

Date Initiated: December 8, 2017

Date Posted: March 21, 2018

Recall Number: Z-0980-2018

Event ID: 79385

Reason for Recall:

Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.

Status: Terminated

Product Quantity: 12

Code Information:

PN: 113617, LN: 552850, UDI# - (01) 00880304554184 (17) 271014 (10) 552850

Distribution Pattern:

US Nationwide in the states of MN, NJ, CA, TX, ND

Voluntary or Mandated:

Voluntary: Firm initiated