Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 7, 2013
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.
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 th…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Custom Spine, Inc. recalled Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile… - a moderate-severity action.
Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile… was recalled by Custom Spine, Inc. in August 7, 2013. Reason: On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out …. Check the official notice for the remedy. Verify recall #Z-1819-2013 with the FDA Devices before acting.
The recall
Custom Spine, Inc. issued this moderate-severity FDA Devices recall-On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out ….
- Moderate
- severity level
- 18 units
- affected scope
- Class II
- classification
- August 7, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1819-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1819-2013) was formally reported on August 7, 2013, with the manufacturer initiating the action on March 28, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Custom Spine, Inc. is listed as the recalling firm, operating out of Parsippany, NJ. Federal records list the affected scope as 18 units.
The documented reason for this recall is: 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 s… Distribution data in the federal record shows the product reached: Nationwide Distribution including Nebraska and Virginia.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
18 units
Related Recalls
6
3 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1819-2013 |
| Date reported | August 7, 2013 |
| Date initiated | March 28, 2013 |
| Recalling firm | Custom Spine, Inc. |
| Firm location | Parsippany, NJ |
| Affected scope | 18 units |
| Distribution | Nationwide Distribution including Nebraska and Virginia. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1819-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Custom Spine, Inc.. Units affected: 18 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2013. Severity: Moderate. Recall number: Z-1819-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including Nebraska and Virginia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1819-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 7, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.