FDA Medical Device Recalls (openFDA)
Exactech, Inc.: REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
- Recall number
- Z-2363-2012
- Recalling firm
- Exactech, Inc.
- Product
- REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
- Status
- Terminated
- Initiated
- 2012-01-24
- Posted
- 2012-09-11
- Terminated
- 2012-09-26
- Reason
- Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
- Root cause
- Finished device change control
- Action
- The firm, Exactech, Inc., called the lone customer on January 24, 2012 to discuss the product, problem and actions to be taken. The customer was instructed to return all unused devices and associated packaging.
- Quantity
- 2
- Distribution
- Nationwide distribution: USA state of: Arkansas only
- Lot, serial or model codes
- Catalog Number: 101-05-40. Serial Numbers:2193123 and 2193124.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTW
- 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