Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1543-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.

Product Classification:

Class II

Date Initiated: February 17, 2020

Date Posted: April 1, 2020

Recall Number: Z-1543-2020

Event ID: 85073

Reason for Recall:

A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.

Status: Terminated

Product Quantity: 14 units

Code Information:

Lot No. 659260, UDI Number: (1)00880304462649(17)290814(10)659260

Distribution Pattern:

International distribution in the countries of Canada, Japan, Netherlands, South Korea.

Voluntary or Mandated:

Voluntary: Firm initiated