Device recall: Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502…
Class II FDA enforcement event 72878. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
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
Innovasis, Inc started this device recall on 7 Dec 2015. The firm address in the FDA record is in Salt Lake City, UT. FDA put the recall in Class II. FDA event 72878 has 1 product record. The first FDA enforcement report date is 27 Jan 2016. The record gives the status Terminated, with the termination date 7 Apr 2016.
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 US -- CA; KS; OH; & TX.
Recalling firm
Innovasis, Inc, Salt Lake City, UT.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0662-2016 | Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine. | 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package | Class II | Terminated | 27 Jan 2016 |
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 2015
- 1,153
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 May 2026 | Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System | Device | Class II | 1 |
| 14 Aug 2024 | TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion | Device | Class II | 1 |
| 7 Apr 2020 | Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical | Device | Class II | 1 |
| 8 Jan 2018 | Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide | Device | Class II | 1 |
| 5 May 2017 | Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Produ | Device | Class II | 1 |
| 7 Jul 2014 | Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0662-2016The 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.
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Cite this page
Recall Register. FDA enforcement event 72878. https://recallregister.com/fda/ii/72878/. 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 US -- CA; KS; OH; & TX.
- What quantity of product is in FDA event 72878?
- The FDA record gives this quantity:
17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.