Custom Spine, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1819-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 28, 2013

Date Posted: August 7, 2013

Recall Number: Z-1819-2013

Event ID: 65068

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.

Status: Terminated

Product Quantity: 18 units

Code Information:

Catalog Number 048545; Lot Number L363

Distribution Pattern:

Nationwide Distribution including Nebraska and Virginia.

Voluntary or Mandated:

Voluntary: Firm initiated