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.

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 indicate A total of 5-pieces of each part number distributed units are affected.

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.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.