Z-1819-2013Class II

Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc...

Name: Z-1819-2013 Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc...
Creator: Custom Spine, Inc.
Published: 2013-03-28
License: https://open.fda.gov/license/

Custom Spine, Inc. / initiated 2013-03-28 / Terminated / root cause: manufacturing process

FDA source

Custom Spine, Inc. began a recall of Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL... on 2013-03-28. FDA classified it as Class II and gives the reason as "On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw...". 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-1819-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-28
Posted: 2013-07-29
Terminated: 2013-10-24
Recalling firm: Custom Spine, Inc.
Product: Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm, but its length measured 40mm.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Custom Spine initiated a voluntary removal On 3/28/2013, Custom Spine initiated a voluntary removal of all 10 pieces of the ISSYS LP (8.5mm X 45mm screws) Lot 363. Distributors were contacted via phone and/or email and were asked to immediately return these parts to Custom Spine.
Quantity in commerce: 18 units
Distribution: Nationwide Distribution including Nebraska and Virginia.
Product codes and lots: Catalog Number 048545; Lot Number L363

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1819-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1819-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29

Product code NKB

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)