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 prevent proper driver fit or cause stripping.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 device failure (stripped screw) during use, representing a risk of harm 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 Screw, and 002, 003, and 004 for the Small Set Screw. The total quantity involved is 397 units.
The recall was initiated because manufacturing controls identified size discrepancies in the drive feature of the screws. These discrepancies may result in the set screw drive feature not accepting the Set Screw Driver (PN: 79-1006) or the driver becoming wedged in the corners of the drive feature, potentially leading to a stripped set screw.
The affected products were distributed in the US. Users should check their inventory for the specific part numbers and lot numbers listed above. If the products are found, they should be removed from use and returned to Orthofix, Inc. according to the company's instructions.
The recalled product
- Product
- ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
- Manufacturer
- Orthofix, Inc
- Affected units
- 397
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 (3)
- UDI 18257200125371
- Lot Numbers: O02
- O03 and O04
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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