T.A.G. MEDICAL PRODUCTS CORPORATION product recalled over possible metal fragments

Recall date

May 4, 2023

Source

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

Official notice title

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. recalls BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural li…

Recall number

Z-2063-2023

FDA classification

Class II

Brand / firm

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.

Why it was recalled

Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.

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

What was recalled

BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045151