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Recall Observatory FDA recall evidence

Device 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.

Z-2071-2015

May 21, 2015

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 71501
Status
Terminated
Classification
Class II
Quantity
2 devices.
Official record key
device-enforcement:Z-2071-2015

Official wording

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

Code information: Catalog Number 05-109-14-0000, Lot # 68266001.

Distribution pattern: Nationwide Distribution to Florida only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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