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Zimmer Biomet, Inc. recalls Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in
Recalled May 16, 2018 · FDA recall Z-1705-2018 · Zimmer Biomet
Hazard
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. · FDA Class II
Units
13175
Sold at
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.
Description
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.
Product
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →