The Recall Desk

FDA (Devices) recall action 71501

Exactech, Inc. recalled 2 products on 2015-07-22

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-07-22
Critical
0
Units
6

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··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.

    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 hist
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2015-07-22

    Exactech Single Barrel Drill Guides Recalled for Incomplete Final Inspection

    Exactech, Inc. is recalling two Single Barrel Drill Guides shipped to a single consignee in Florida before final inspection was completed.

    Product
    Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
    Category
    Distribution
    1 state