Biomet, Inc. recalls A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedur…

Recall date

November 20, 2015

Source

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

Recall number

Z-0450-2016

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR CHILE, COSTA RICA, NETHERLANDS, CANADA

Why it was recalled

These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If the screw does not lock into the plate; the screw may back out. If the screw sits proud, soft tissue irritation may occur. If the screw does not lock into the plate and backs out, a revision surgery may be necessary.

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

What was recalled

A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones.