Zimmer Biomet, Inc. recalls Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pe…

Recall date

April 5, 2018

Source

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

Recall number

Z-1705-2018

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

worldwide Distribution - US Distribution to the states of : CA, FL, MO, NC, SC, TX, and WI., and to the countries of : Argentina, China, Colombia, Germany, Japan, Netherlands, South Africa, Thailand, and Vietnam.

Why it was recalled

The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.

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

What was recalled

Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.