Custom Spine ISSYS LP Inverted Screw System — Class II medical device recall Z-1819-2013
Terminated recall by Custom Spine, Inc., reported 2013-08-07, distributed nationwide. On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out o
| Recall number | Z-1819-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Custom Spine, Inc., Parsippany, NJ, United States |
| Recall initiated | 2013-03-28 |
| Classified | 2013-07-29 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2013-10-24 |
| Distributed | Nationwide (US) |
| Quantity | 18 units |
| Reason classes | specification failure |
| Lot numbers | L363 |
| Model numbers | 048545 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1819-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.