Z-0203-2016Class II

MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior...

Name: Z-0203-2016 MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior...
Creator: Biomet Spine, LLC
Published: 2015-09-29
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2015-09-29 / Terminated / root cause: labeling and UDI

FDA source

Biomet Spine, LLC began a recall of MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based... on 2015-09-29. FDA classified it as Class II and gives the reason as "The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0203-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-29
Posted: 2015-11-03
Terminated: 2016-04-29
Recalling firm: Highridge Medical, LLC
Product: MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Zimmer Biomet Spine sent an Urgent Medical Device Recall Notice dated September 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the device has already been implanted, written confirmation of this will be required and the necessary parties will be contacted. They will store returned product in quarantine in an isolated location until they can undergo inspection to verify if they are conforming or not and then will be destroyed or retained. Necessary parts will be destroyed so that it is visually obvious they are no longer functional. For further questions call (303) 443-7500 ext.244.
Quantity in commerce: 17 units
Distribution: US Distribution to the states of : NY, MO, and FL
Product codes and lots: P/N: 14-521550; Lot Numbers: 463870; P/N: 14-521548; Lot Numbers: J86056; P/N: 14-521518; Lot Numbers: J26394; Model Numbers: 14-521518 14-521520 14-521548 14-521550

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0203-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0203-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-03

Product code KWQ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)