Zimmer Biomet, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1960-2019)

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:

Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509

Product Classification:

Class II

Date Initiated: June 10, 2019

Date Posted: July 24, 2019

Recall Number: Z-1960-2019

Event ID: 83099

Reason for Recall:

Lack of an adequate sterilization validation.

Status: Terminated

Product Quantity: 92

Code Information:

Lots: 262549 266083 1441011 M642860 2881015 3021022 3081051 266083 2591050 2771027 3231028 MJ54320 MJ54330 MJ54350 MJ54340

Distribution Pattern:

The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated