Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2070-2015·Announced 2015-07-22

Exactech Recalls Four Ambassador Cervical Plate Systems

Exactech, Inc. is recalling four Ambassador Cervical Plate Systems that were shipped to a single consignee in Florida before final inspection was completed.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the devices were shipped prior to final inspection without reporting any illnesses or injuries, fitting the criteria for a voluntary precautionary recall or low-risk contamination/defect.

Plain-English summary

Exactech, Inc. is recalling four units of the Ambassador Cervical Plate System. The recall is limited to devices with Catalog Number 05-100-03-0042 and Lot # 68122001. The product is intended for anterior cervical fixation for conditions such as degenerative disc disease, spondylolisthesis, and trauma.

The recall was initiated because the devices were shipped to a single consignee prior to the completion of final inspection. The distribution was limited to Florida. The source text does not report any illnesses, injuries, or deaths associated with these specific units.

Consumers and healthcare providers who possess these specific devices should contact Exactech, Inc. for instructions on how to return or replace the product. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

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…
Manufacturer: Exactech, Inc.
Category: Medical Device — Orthopedic / Spinal
Hazard: quality-control
uninspected-device
Affected units: 4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Catalog Number 05-100-03-0042
Lot # 68122001.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Exactech, Inc.

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