—#138003

Product

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 product code: KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K142576
Affected lot / code info: Catalog Number 05-100-03-0042, Lot # 68122001.

Why it was recalled

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

Root cause (FDA determination)

Release of Material/Component prior to receiving test results

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: Nationwide Distribution to Florida only.

Timeline

Recall initiated: 2015-05-21
Posted by FDA: 2015-07-14
Terminated: 2015-07-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138003. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.