FDA Device recall Z-1364-2018
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002 by Orthofix, citing 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 affec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1364-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-23 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orthofix |
| Distribution | n/a |
Product
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
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.
Identifiers
| code_info | UDI 18257200125364, Lot Numbers: O01 and O02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1364-2018%22
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