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Terminated

Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

FDA Recall Z-2070-2015 · Posted 2015-07-14

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeKWQ
Date Initiated2015-05-21
Date Terminated2015-07-16
Product Quantity4 devices.

Reason for Recall

Shipped to a single consignee prior to completion of final inspection.

Firm Action

Exactech contacted their consignee by telephone on May 21, 2015, of this recall for their two products and instructed him to recover the devices from the hospital. Devices were recovered from the hospital May 22, 2015, and returned to the firm on May 26. All devices have been recovered.

Root Cause

Release of Material/Component prior to receiving test results

Distribution Pattern

Nationwide Distribution to Florida only.

Official Source

View FDA Recall →

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

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