CLASS II Device recall · Reported 22 Jul 2015 · FDA Enforcement Report
Ambassador Cervical Plate System The Exactech Ambassador recalled
Exactech is recalling Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System, distributed nationwide in the US. The recall was initiated on 21 May 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2070-2015
- FDA event ID
- 71501
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 May 2015
- FDA classified
- 14 Jul 2015
- Reported
- 22 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Processing Deviation
- Device type
- Spinal Implants
Timeline
| 21 May 2015 | Recall initiated by company | |
| 14 Jul 2015 | Classified by FDA | +54 days |
| 22 Jul 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Shipped to a single consignee prior to completion of final inspection.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution to Florida only.
Questions about this recall
Is Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is recalled?
Yes. Exactech recalled Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is on 21 May 2015. The recall is Class II and its status is Terminated. Recall number Z-2070-2015.
Why was it recalled?
Shipped to a single consignee prior to completion of final inspection.
Which lots are affected?
Catalog Number 05-100-03-0042, Lot # 68122001.
Where was it sold?
Nationwide Distribution to Florida only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Exactech
All 197| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Equinoxe Core Instrument Kit recalled by Exactech | Exactech | Other | 19 states |
| Device | CLASS II | Equinoxe Ergo Ergo Modular Impactor Handle recalled by Exactech | Exactech | Other | 19 states |
| Device | CLASS II | Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech | Exactech | Device Malfunction | SC |
| Device | CLASS II | Equinoxe Ergo Ergo Augments Pilot Tip Converter recalled by Exactech | Exactech | Device Malfunction | SC |
| Device | CLASS II | Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech | Exactech | Device Malfunction | SC |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |