FDA Device recall Z-2600-2018
Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and t…
- FDA Device
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and t… by Encore Medical, citing A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2600-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-26 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Encore Medical |
| Distribution | AZ, CA, CO, FL, IN, MI, MN, MO, NJ, NV, NY, OH, RI, SC, TN, TX, UT, WA |
Product
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
A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
Identifiers
| code_info | 804-99-129 Vendor Lot #22747003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2600-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.