Stelkast Co recalls EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee rep…

Recall date

December 1, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0970-2015

FDA classification

Class II

Brand / firm

Stelkast Co

Sold / distributed

TX, MD, IN, KS, CA, PA, GA, WA, NY, IL.

Why it was recalled

Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.