Orthofix Recalls Connector System Set Screws Due to Size Discrepancies
Orthofix is voluntarily recalling specific lots of Connector System set screws because size discrepancies may cause the driver to wedge or strip the screw.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could lead to a stripped screw during a procedure. Per the rubric, this is classified as High (Score 3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Orthofix, Inc. is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) and Small Set Screw (PN: 79-2003). The recall affects specific lot numbers: 001 and 002 for the large set screws, and 002, 003, and 004 for the small set screws. The total quantity involved is 188 units, distributed within the United States.
The recall was initiated after the company's manufacturing controls identified size discrepancies in the drive feature of both the large and small set screws. These discrepancies may result in two potential issues: the set screw drive feature may not accept the Set Screw Driver (PN: 79-1006), or the driver may become wedged in the corners of the drive feature (a "false bottom"), which could lead to a stripped set screw.
No injuries or illnesses have been reported in connection with this recall. Healthcare providers and facilities should stop using the affected set screws and contact Orthofix for instructions on returning the product.
The recalled product
- Product
- ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
- Manufacturer
- Orthofix, Inc
- Affected units
- 188
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI 18257200125364
- Lot Numbers: O01 and O02
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Orthofix, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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