Z-2600-2018 Class II Terminated
FDA device recall Z-2600-2018 was initiated by Encore Medical, Lp on Jun 26, 2018 and is designated Class II. Reason for recall: A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible. The recall status is terminated (terminated Aug 22, 2023). Affected quantity: 30 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 8, 2018
- Initiation Date
- Jun 26, 2018
- Termination Date
- Aug 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
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.
Reason for Recall
A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
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.
Code Information
804-99-129 Vendor Lot #22747003
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2600-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026