PlainRecalls
FDA Devices Moderate Class II 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 previou

Reported: July 22, 2015 Initiated: May 21, 2015 #Z-2070-2015

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Exactech, Inc.
Units Affected
4 devices.
Distribution
Nationwide Distribution to Florida only.
Location
Gainesville, FL

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Exactech, Inc.. Units affected: 4 devices..
Why was this product recalled? ▼
Shipped to a single consignee prior to completion of final inspection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 22, 2015. Severity: Moderate. Recall number: Z-2070-2015.

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