# FDA recall Z-0586-2024

> **Exactech, Inc.** · Class II · device recall initiated 2023-11-21.

## Product

Exactech Truliant, Activit-E Knee Insert, Catalog Numbers:    a)	02-023-02-0029,   b)	02-023-02-0032,   c)	02-023-02-0035,   d)	02-023-02-0038,   e)	02-024-35-1512,   f)	02-024-35-1515,   g)	02-024-35-1519,   h)	02-024-35-2010,   i)	02-024-35-2013,   j)	02-024-35-2015,   k)	02-024-35-2509,   l)	02-024-35-2510,   m)	02-024-35-2511,   n)	02-024-35-2512,   o)	02-024-35-3010,   p)	02-024-35-3011,   q)	02-024-35-3012,   r)	02-024-35-3013,   s)	02-024-35-3513,   t)	02-024-35-3515,   u)	02-024-35-4012,   v)	02-024-35-4013,   w)	02-024-35-4510,   x)	02-024-35-4515,   y)	02-024-35-5011,   z)	02-024-35-5012,   aa)	02-024-44-1511,   bb)	02-024-44-2009,   cc)	02-024-44-2011,   dd)	02-024-44-2015,   ee)	02-024-44-2510,   ff)	02-024-44-2515,   gg)	02-024-44-3009,   hh)	02-024-44-3011,   ii)	02-024-44-3013,   jj)	02-024-44-3015,   kk)	02-024-44-3509,   ll)	02-024-44-4009,   mm)	02-024-44-4509,   nn)	02-024-44-4511,   oo)	02-024-44-4512,   pp)	02-024-44-4513,   qq)	02-024-44-5013

## Reason for recall

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

## Distribution

US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK

## Key facts

- **Recall number:** Z-0586-2024
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-21
- **Report date:** 2023-12-27

- **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-0586-2024

## Citation

> AI Analytics. FDA recall Z-0586-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0586-2024. Source: US FDA. Licensed CC0.

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