ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
This recall has been terminated (originally issued February 23, 2018).
- Company
- Orthofix, Inc
- Recall Initiated
- February 23, 2018
- Terminated
- June 18, 2019
- Recall Number
- Z-1364-2018
- Quantity
- 188 units
- Firm Location
- Lewisville, TX
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US
Lot / Code Info
UDI 18257200125364, Lot Numbers: O01 and O02
Root Cause
Nonconforming Material/Component
Action Taken
The firm disseminated the recall notices on 02/23/2018 by mail. The firm requested the return of the screws.