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Open, Classified

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

FDA Recall Z-0582-2024 · Posted 2024-01-18

Recalling FirmExactech, Inc.
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2023-11-21

Reason for Recall

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

Firm Action

Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email.

Root Cause

Packaging change control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160484Optetrak Advanced PatellaExactech, Inc. · 2016-03-18K954208OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLYExactech, Inc. · 1996-02-26K932690EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SYExactech, Inc. · 1995-02-09K933610EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTSExactech, Inc. · 1995-01-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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