Encore Medical, Lp: Medical Device Recall in 2018 - (Recall #: Z-2600-2018)

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:

Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrumentation by end users.

Product Classification:

Class II

Date Initiated: June 26, 2018

Date Posted: August 8, 2018

Recall Number: Z-2600-2018

Event ID: 80445

Reason for Recall:

A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.

Status: Terminated

Product Quantity: 30 units

Code Information:

804-99-129 Vendor Lot #22747003

Distribution Pattern:

US Distribution to states of; AZ, CA, CO, FL, IN, NJ, NY, NV, MI, MN, MO, OH, RI, SC, TN, TX, UT and WA and country of; Japan.

Voluntary or Mandated:

Voluntary: Firm initiated