Device recall: Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and…
Class III FDA enforcement event 53487. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Spinal Elements, Inc started this device recall on 17 Apr 2009. The firm address in the FDA record is in Carlsbad, CA. FDA put the recall in Class III. FDA event 53487 has 21 product records. The first FDA enforcement report date is 15 May 2013. The record gives the status Terminated, with the termination date 7 May 2013.
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.
Distributed in OH and PA.
Recalling firm
Spinal Elements, Inc, Carlsbad, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
21 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1246-2013 | Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1247-2013 | Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1248-2013 | Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1249-2013 | Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1250-2013 | Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1251-2013 | Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1252-2013 | Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1253-2013 | Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1254-2013 | Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1255-2013 | Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1256-2013 | Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1257-2013 | Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1258-2013 | Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1259-2013 | Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1260-2013 | Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1261-2013 | Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1262-2013 | Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1263-2013 | Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1264-2013 | Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1265-2013 | Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
| Z-1266-2013 | Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | 68 units total | Class III | Terminated | 15 May 2013 |
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 III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2009
- 26
- Share of these events in Class III
- 12%
- Product records in this event
- 21Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Apr 2015 | Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of scr | Device | Class III | 1 |
| 18 Dec 2014 | Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1246-2013The 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 53487. https://recallregister.com/fda/iii/53487/. 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:
Distributed in OH and PA.
- What quantity of product is in FDA event 53487?
- The event has 21 product records. The first record gives this quantity:
68 units total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2009 have the same class?
- 12% of the 26 device events that started in 2009 are in Class III.