Recall Z-0583-2024— Exactech, Inc.
Class II · Ongoing
Class II FDA medical device recall by Exactech, Inc., initiated 2023-11-21. It names 2 FDA 510(k) clearances: K150890, K111400. Product: Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013. Reason: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag..
- Recalling firm
- Exactech, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-21
- Firm location
- Gainesville, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K150890 — Exactech Optetrak Logic CC
- K111400 — OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
Reason for recall
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Data sourced from openFDA. This site is unofficial and independent of the FDA.