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Terminated

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.

FDA Recall Z-2136-2014 · Posted 2014-08-01

Recalling FirmX Spine Systems Inc
Recall StatusTerminated
Product CodeFZX
Date Initiated2014-07-11
Date Terminated2014-08-14
Product QuantityA total of 5-pieces of each part number distributed

Reason for Recall

Revision B of the tissue shields of the device was 7 mm longer than the previous design.

Firm 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

Root Cause

Employee error

Distribution Pattern

US Distribution including the states of FL and MO.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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