Reported Jul 22, 2015 · Terminated
Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior…
Exactech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exactech, Inc. · 2320 NW 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical
- fixation (C2-T1) for the followingdegenerative 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
- Lot codes and dates
Catalog Number 05-100-03-0042Lot # 68122001
- Amount recalled
- 4 devices.
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- FL
Why it was recalled
Shipped to a single consignee prior to completion of final inspection.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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