The Recall Desk
ModerateFDA (Devices)·Z-1819-2013·Announced 2013-08-07

Custom Spine ISSYS LP Inverted Screw System Recall for Dimensional Defect

Custom Spine, Inc. is recalling 18 ISSYS LP Inverted Screws that were 5 mm shorter than the labeled specification.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The source text explicitly describes the action as a 'minor removal' and identifies the defect as a dimensional specification error without reporting any injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Custom Spine, Inc. issued a minor removal of a lot of 18 ISSYS LP Inverted Screws on March 28, 2013. The recalled product is the 8.5mm x 45mm ISSYS LP Screw, Catalog Number 048545, Lot Number L363. These screws are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine.

The recall was initiated because the screws were found to be out of specification. Although the product is laser marked as 8.5mm x 45mm, the actual length measured 40mm, which is 5 mm shorter than the required specification for that screw size.

The 18 units were distributed nationwide, including in Nebraska and Virginia. The source text does not specify specific actions for consumers or healthcare providers beyond the issuance of the removal notice.

The recalled product

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
Manufacturer
Custom Spine, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
18

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Catalog Number 048545
  • Lot Number L363

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

Same hazard · dimensional defect

See all →