Z-2070-2015 Class II Terminated
FDA device recall Z-2070-2015 was initiated by Exactech, Inc. on May 21, 2015 and is designated Class II. Reason for recall: Shipped to a single consignee prior to completion of final inspection. The recall status is terminated (terminated Jul 16, 2015). Affected quantity: 4 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 22, 2015
- Initiation Date
- May 21, 2015
- Termination Date
- Jul 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 devices.
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.
Distribution Pattern
Nationwide Distribution to Florida only.
Code Information
Catalog Number 05-100-03-0042, Lot # 68122001.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2070-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026