FDA Medical Device Recalls (openFDA)
Orthofix, Inc: ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
- Recall number
- Z-1363-2018
- Recalling firm
- Orthofix, Inc
- Product
- ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
- Status
- Terminated
- Initiated
- 2018-02-23
- Posted
- not on file
- Terminated
- 2019-06-18
- Reason
- Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.
- Root cause
- Nonconforming Material/Component
- Action
- The firm disseminated the recall notices on 02/23/2018 by mail. The firm requested the return of the screws.
- Quantity
- 397 units
- Distribution
- US
- Lot, serial or model codes
- UDI 18257200125371, Lot Numbers: O02, O03 and O04
- 510(k) numbers
- ["K172194"]
- PMA numbers
- not on file
- Product code
- NKG
- Firm FEI
- 2183449
- Firm city
- Lewisville
- Firm state
- TX
- 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