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U.S. Department of Health and Human Services

Class 2 Device Recall ORTHOFIX, Connector System, LARGE SET SCREW

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  Class 2 Device Recall ORTHOFIX, Connector System, LARGE SET SCREW see related information
Date Initiated by Firm February 23, 2018
Create Date April 11, 2018
Recall Status1 Terminated 3 on June 18, 2019
Recall Number Z-1364-2018
Recall Event ID 79498
510(K)Number K172194  
Product Classification Orthosis, cervical pedicle screw spinal fixation - Product Code NKG
Product ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
Code Information UDI 18257200125364, Lot Numbers: O01 and O02
Recalling Firm/
Manufacturer		 Orthofix, Inc
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information Contact
469-742-2500
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm disseminated the recall notices on 02/23/2018 by mail. The firm requested the return of the screws.
Quantity in Commerce 188 units
Distribution US
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NKG and Original Applicant = Orthofix Inc.
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