# FDA recall Z-2644-2017

> **Exactech, Inc.** · Class II · device recall initiated 2017-05-22.

## Product

Exactech 1.5" Novation Calcar Planer Guide Tip    To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.      ech 1.5" Novation Calcar Planer Guide Tip

## Reason for recall

The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform  calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.

## Distribution

Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of :  AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, RI, SC, TN, TX, VA, WA,  WI, Hawaii., and to the countries of : Argentina, Australia, Austria, Brazil, China, Colombia, France, Germany, Guatemala, India, Italy, Japan, Spain, Switzerland, Turkey, and United Kingdom

## Key facts

- **Recall number:** Z-2644-2017
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-22
- **Report date:** 2017-07-05
- **Termination date:** 2019-07-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2644-2017

## Citation

> AI Analytics. FDA recall Z-2644-2017. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2644-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*