Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ORTHOFIX Recalled by Orthofix, Inc Due to Orthofix is conducting a voluntary recall of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Orthofix, Inc directly.
Affected Products
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
Quantity: 188 units
Why Was This 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.
Where Was This Sold?
US
About Orthofix, Inc
Orthofix, Inc has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report