Spinal Elements, Inc

FDA recalling firm · 3 enforcement events · 23 product records · 2009–2015 · CA

Spinal Elements, Inc has 3 FDA enforcement events on this register (23 product records) between 2009 and 2015: 3 device; the busiest year was 2009 with 1.

0% of its events are Class I; the most common class is Class III (2). 0 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
9 Apr 2015	Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of…	Device	Class III	1	Terminated
18 Dec 2014	Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.	Device	Class II	1	Terminated
17 Apr 2009	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.	Device	Class III	21	Terminated

By type and class

Device3

Class III2

Class II1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Spinal Elements, Inc by year initiated.

Questions and answers

How many FDA recalls has Spinal Elements, Inc had?

3 enforcement events (23 product records) on this register, 2009–2015: 3 device.

Are any Spinal Elements, Inc recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Spinal Elements, Inc recalls?

2 Class III, 1 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.