Stradis Medical, LLC dba Stradis Healthcare: Medical Device Recall in 2022 - (Recall #: Z-0864-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Total Knee Pack - Surgical Kit

Product Classification:

Class II

Date Initiated: February 25, 2022

Date Posted: April 13, 2022

Recall Number: Z-0864-2022

Event ID: 89671

Reason for Recall:

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

Status: Ongoing

Product Quantity: 76 units

Code Information:

SKU/Part Number 570-2676; UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064

Distribution Pattern:

US Nationwide distribution in the states of IN, TX, and PA.

Voluntary or Mandated:

Voluntary: Firm initiated