CONNECTOR recallZ-1363-2018 · Orthofix, Inc · initiated Feb 23, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Orthofix, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The firm disseminated the recall notices on 02/23/2018 by mail. The firm requested the return of the screws.
Recall details
- Recall number
- Z-1363-2018
- Status
- Terminated
- Initiated by the company
- Feb 23, 2018
- Recalling firm
- Orthofix, Inc
- Quantity
- 397 units
- Product code
- NKG
- FDA submissions
- K172194
- Distribution
- US
Product description
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Code information (models, lots, serial numbers)
UDI 18257200125371, Lot Numbers: O02, O03 and O04
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 79498).
- Z-1364-2018 · TerminatedORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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