# FDA recall Z-2600-2018

> **Encore Medical, Lp** · Class II · device recall initiated 2018-06-26.

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-2600-2018
- **Recalling firm:** Encore Medical, Lp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-26
- **Report date:** 2018-08-08
- **Termination date:** 2023-08-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2600-2018

## Citation

> AI Analytics. FDA recall Z-2600-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2600-2018. Source: US FDA. Licensed CC0.

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