Recall Z-2744-2015— Biomet Spine, LLC

Name: FDA recall Z-2744-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-05

Class II · Terminated

Class II FDA medical device recall by Biomet Spine, LLC, initiated 2015-08-05, terminated 2016-02-10. It names one FDA 510(k) clearance: K080646. Product: Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.. Reason: Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440..

Recalling firm: Biomet Spine, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-08-05
Terminated: 2016-02-10
Firm location: Broomfield, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K080646 — C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEMBiomet Spine·cleared 2008-05-02

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 Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.

Reason for recall

Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.

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