Recall Z-0582-2024— Exactech, Inc.
Class II · Ongoing
Class II FDA medical device recall by Exactech, Inc., initiated 2023-11-21. It names 4 FDA 510(k) clearances: K160484, K954208, K932690 and 1 more. Product: Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13. 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
4 on FDA's record- K160484 — Optetrak Advanced Patella
- K954208 — OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY
- K932690 — EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY
- K933610 — EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS
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 Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13
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.