Z-2136-2014Class II

Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System...

Name: Z-2136-2014 Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System...
Creator: X Spine Systems Inc
Published: 2014-07-11
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2014-07-11 / Terminated / root cause: manufacturing process

FDA source

X Spine Systems Inc began a recall of Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument... on 2014-07-11. FDA classified it as Class II and gives the reason as "Revision B of the tissue shields of the device was 7 mm longer than the previous design". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2136-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-11
Posted: 2014-08-01
Terminated: 2014-08-14
Recalling firm: Xtant Medical Holdings, Inc.
Product: Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
Product code: FZX Guide, Surgical, Instrument
Reason for recall: Revision B of the tissue shields of the device was 7 mm longer than the previous design.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: X-Spine systems contacted both customers via telephone and instructed to return the affected product back to X-Spine. All product has been recovered. The distributors have already returned the recalled product. No product was utilized in any surgical procedure. Immediate Action Taken: X-spine inventory was reviewed and two pieces of each size were recovered from finished inventory. The X-spine sales person returned the product. The distributor has returned the remaining product. The devices were recovered prior to use in any surgical procedure. For further questions please call (937) 847-8410
Quantity in commerce: A total of 5-pieces of each part number distributed
Distribution: US Distribution including the states of FL and MO.
Product codes and lots: Part numbers X079-0096 and X079-0097 with Lot #12320

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2136-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2136-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-01

Product code FZX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)