—#204596

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

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K111400, K150890
Affected lot / code info: a) 02-012-47-3011, GTIN 10885862174352, Serial Numbers: A676497; b) 02-012-47-5009, GTIN 10885862174543, Serial Numbers: A641353; c) 02-012-47-5011, GTIN 10885862174550, Serial Numbers: A641341; d) 02-012-65-3013, GTIN 10885862613400, Serial Numbers: A655561

Why it was recalled

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

Root cause (FDA determination)

Packaging change control

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 Nw 66th Ct, Gainesville, Florida 32653-1630

Distribution

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

Timeline

Recall initiated: 2023-11-21
Posted by FDA: 2024-01-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204596. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.