Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 13, 2014
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.
Revision B of the tissue shields of the device was 7 mm longer than the previous design.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
X Spine Systems Inc recalled Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroil… - a moderate-severity action.
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroil… was recalled by X Spine Systems Inc in August 13, 2014. Reason: Revision B of the tissue shields of the device was 7 mm longer than the previous design.. Check the official notice for the remedy. Verify recall #Z-2136-2014 with the FDA Devices before acting.
The recall
X Spine Systems Inc issued this moderate-severity FDA Devices recall-Revision B of the tissue shields of the device was 7 mm longer than the previous design..
- Moderate
- severity level
- Class II
- classification
- August 13, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2136-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2136-2014) was formally reported on August 13, 2014, with the manufacturer initiating the action on July 11, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. X Spine Systems Inc is listed as the recalling firm, operating out of Miamisburg, OH. Federal records list the affected scope as A total of 5-pieces of each part number distributed.
The documented reason for this recall is: Revision B of the tissue shields of the device was 7 mm longer than the previous design. Distribution data in the federal record shows the product reached: US Distribution including the states of FL and MO.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
A total of 5-pieces of each part number distributed
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
Revision B of the tissue shields of the device was 7 mm longer than the previous design.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2136-2014 |
| Date reported | August 13, 2014 |
| Date initiated | July 11, 2014 |
| Recalling firm | X Spine Systems Inc |
| Firm location | Miamisburg, OH |
| Affected scope | A total of 5-pieces of each part number distributed |
| Distribution | US Distribution including the states of FL and MO. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2136-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by X Spine Systems Inc. Units affected: A total of 5-pieces of each part number distributed.
Why was this product recalled? ▼
Revision B of the tissue shields of the device was 7 mm longer than the previous design.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 13, 2014. Severity: Moderate. Recall number: Z-2136-2014.
Where was the recalled product distributed? ▼
Distribution: US Distribution including the states of FL and MO..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2136-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 13, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.