Z-0325-2018Class II

Mac Pin Non-Cannulated Screw, 6.5 x 60mm

Name: Z-0325-2018 Mac Pin Non-Cannulated Screw, 6.5 x 60mm
Creator: Amendia, Inc
Published: 2017-07-07
License: https://open.fda.gov/license/

Spinal Elements, Inc / initiated 2017-07-07 / Terminated / root cause: manufacturing process

FDA source

Amendia, Inc began a recall of Mac Pin Non-Cannulated Screw, 6.5 x 60mm on 2017-07-07. FDA classified it as Class II and gives the reason as "Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0325-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-07
Posted: 2018-01-10
Terminated: 2019-10-15
Recalling firm: Spinal Elements, Inc
Product: Mac Pin Non-Cannulated Screw, 6.5 x 60mm
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were sent recall notification letters on 07/07/2017. Instructions included to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia, and to complete and return the questionnaire. If there are questions, Amendia Customer Service can be contacted at 770-575-5224.
Quantity in commerce: 41 screws
Distribution: Distribution to Georgia, USA.
Product codes and lots: Model #85-6560-1, Lot #132117

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0325-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0325-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-10

Product code NKB

K153152Class IISyzygy Stabilization SystemAmendia, Inc. / cleared 2016-04-27

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)