Food, drugs, devices › X Spine Systems Inc
Device recall: Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisbur
X Spine Systems Inc (Miamisburg, OH) initiated this device recall on 7 Apr 2015; FDA lists 1 product record under event 71357, classified Class II.
FDA defines Class II as 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 1 Oct 2015. Initiation: voluntary: firm initiated. X Spine Systems Inc has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
X Spine Systems Inc, Miamisburg, OH.
Reason for recall
"The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length."
Distribution
"Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1823-2015 | Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400 | 75 units | Class II | Terminated | 1 Jul 2015 |
Context
Other enforcement events for X Spine Systems Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 17 May 2016 | Calix P PEEK Lumbar System, PLIF Rasp | Device | Class II | 4 |
| 11 Mar 2015 | Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, ped | Device | Class II | 1 |
| 11 Jul 2014 | Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tiss | Device | Class II | 1 |
All 4 events for X Spine Systems Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Oct 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.