FDA Medical Device Recalls (openFDA)
Exactech, Inc.: 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.
- Recall number
- Z-2071-2015
- 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.
- Status
- Terminated
- Initiated
- 2015-05-21
- Posted
- 2015-07-14
- Terminated
- 2015-07-16
- Reason
- Shipped to a single consignee prior to completion of final inspection.
- 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
- 2 devices.
- Distribution
- Nationwide Distribution to Florida only.
- Lot, serial or model codes
- Catalog Number 05-109-14-0000, Lot # 68266001.
- 510(k) numbers
- ["K143576"]
- PMA numbers
- not on file
- Product code
- KWQ
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28