—#166799

Product

Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K150890
Affected lot / code info: Catalog #: 02-012-60-2216 Serial Number: 5370045

Why it was recalled

Potentially have non-conforming internal threads.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm, Exactech, contacted the consignee on May 3, 2018 by telephone to notify the consignee to quarantine the device pending recall notice distribution. Exactech distributed an "URGENT MEDICAL DEVICE RECALL" notice dated May 7, 2018 to the consignee in possession of affected inventory by electronic mail on May 7, 2018. In order to comply with the notice, consignees have been instructed to: " Immediately cease distribution or use of this product. " Extend the information to their accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in their inventory " Complete and return the attached Recall Acknowledgment Form and Recall Inventory Response Form to Exactech at recalls@exac.com. On May 15, 2018, the recalled device was returned to Exactech and quarantined. If you have any questions, contact Sr. Manager, Regulator Affairs at 352-327-4613.

Recalling firm

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

Distribution

Distribution pattern: US Distribution to Ohio only.

Timeline

Recall initiated: 2018-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166799. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.