Instrument trays used to store AltiVate Small Shell Trials — Class II medical device recall Z-2600-2018
Terminated recall by Encore Medical, Lp, reported 2018-08-08, distributed in AZ, CA, CO, FL, IN, MI, MN, MO…. A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is no
| Recall number | Z-2600-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2018-06-26 |
| Classified | 2018-08-02 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2023-08-22 |
| Distributed | AZ, CA, CO, FL, IN, MI, MN, MO, NJ, NV, NY, OH, RI, SC, TN, TX, UT, WA |
| Countries outside the US | JP |
| Quantity | 30 units |
| Lot numbers | 22747003 |
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 for recall
A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2600-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.