Drug recall
Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9…
FDA recall event 65068 · Class II · Custom Spine, Inc.
Key facts
| Event ID | 65068 |
|---|---|
| Recall numbers | Z-1819-2013 |
| Recalling firm | Custom Spine, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 28, 2013 |
| Report date | Aug 7, 2013 |
| Termination date | Oct 24, 2013 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 3005129649 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: