Device recall: Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
Class II FDA enforcement event 52634. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
NuVasive Inc started this device recall on 5 Jan 2009. The firm address in the FDA record is in San Diego, CA. FDA put the recall in Class II. FDA event 52634 has 31 product records. The first FDA enforcement report date is 28 Nov 2012. The record gives the status Terminated, with the termination date 19 Nov 2012.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Recalling firm
NuVasive Inc, San Diego, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
31 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0348-2013 | Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0349-2013 | 5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0350-2013 | 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0351-2013 | 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0352-2013 | 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0353-2013 | 5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0354-2013 | 5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0355-2013 | 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0356-2013 | 6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0357-2013 | 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0358-2013 | 6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0359-2013 | 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0360-2013 | 6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0361-2013 | 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0362-2013 | 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0363-2013 | 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0364-2013 | 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0365-2013 | 7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0366-2013 | 7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0367-2013 | Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0368-2013 | 4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0369-2013 | 4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0370-2013 | 5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0371-2013 | 5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0372-2013 | 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0373-2013 | 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0374-2013 | 6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0375-2013 | 6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0376-2013 | 7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0377-2013 | 7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
| Z-0378-2013 | 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | 240 units total | Class II | Terminated | 28 Nov 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2009
- 26
- Share of these events in Class II
- 85%
- Product records in this event
- 31Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Nov 2022 | X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation. | Device | Class II | 1 |
| 19 Jul 2022 | NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US | Device | Class III | 1 |
| 20 Jun 2022 | Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Sim | Device | Class II | 1 |
| 10 Jun 2020 | Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for | Device | Class II | 1 |
| 13 Feb 2020 | NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spin | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0348-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 52634. https://recallregister.com/fda/ii/52634/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- What quantity of product is in FDA event 52634?
- The event has 31 product records. The first record gives this quantity:
240 units total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2009 have the same class?
- 85% of the 26 device events that started in 2009 are in Class II.