Recall Z-0137-2016— Biomet Microfixation, LLC

Name: FDA recall Z-0137-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-06

Class II · Terminated

Class II FDA medical device recall by Biomet Microfixation, LLC, initiated 2015-08-06, terminated 2017-10-13. It names one FDA 510(k) clearance: K121624. Product: Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.. Reason: The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force..

Recalling firm: Biomet Microfixation, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-08-06
Terminated: 2017-10-13
Firm location: Jacksonville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K121624 — BIOMET MICROFIXATION NEURO PLATING SYSTEMBiomet Microfixation·cleared 2012-10-12

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

Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.

Reason for recall

The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.

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