Recall Z-1705-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1705-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-05

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-04-05, terminated 2020-08-12. It names one FDA 510(k) clearance: K003281. Product: Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.. Reason: 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..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-04-05
Terminated: 2020-08-12
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K003281 — LACTOSORB RAPIDFLAPBiomet, Inc.·cleared 2001-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.