Zimmer Biomet, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0521-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.

Product Classification:

Class II

Date Initiated: August 21, 2019

Date Posted: December 4, 2019

Recall Number: Z-0521-2020

Event ID: 83783

Reason for Recall:

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

Status: Terminated

Product Quantity: 219988 units (total)

Code Information:

662230

Distribution Pattern:

US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated