Recall Z-0396-2019— Zimmer Biomet, Inc.

Name: FDA recall Z-0396-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-22

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-08-22, terminated 2021-06-17. It names one FDA 510(k) clearance: K031034. Product: Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.. Reason: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-08-22
Terminated: 2021-06-17
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K031034 — SPIN DOWN RAPIDFLAPWalter Lorenz Surgical, Inc.·cleared 2003-05-21

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

Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.

Reason for recall

Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.

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