Recall Z-1363-2018 ยท NKG Posterior Cervical Screw System
Orthofix, Inc
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
| Date | Feb 23, 2018 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172194 | Connector System Orthofix, Inc., Aug 18, 2017 |