Z-2071-2015Class II

Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended...

Name: Z-2071-2015 Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended...
Creator: Exactech, Inc.
Published: 2015-05-21
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2015-05-21 / Terminated

FDA source

Exactech, Inc. began a recall of 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... on 2015-05-21. FDA classified it as Class II and gives the reason as "Shipped to a single consignee prior to completion of final inspection". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2071-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-21
Posted: 2015-07-14
Terminated: 2015-07-16
Recalling firm: Exactech, Inc.
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.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Shipped to a single consignee prior to completion of final inspection.
FDA root cause: Release of Material/Component prior to receiving test results
Action: Exactech contacted their consignee by telephone on May 21, 2015, of this recall for their two products and instructed him to recover the devices from the hospital. Devices were recovered from the hospital May 22, 2015, and returned to the firm on May 26. All devices have been recovered.
Quantity in commerce: 2 devices.
Distribution: Nationwide Distribution to Florida only.
Product codes and lots: Catalog Number 05-109-14-0000, Lot # 68266001.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2071-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2070-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-14
Z-2071-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-14

Product code KWQ

K143576Class IIExactech AmbassadorExactech, Inc. / cleared 2015-02-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)