Z-1174-2013 Class II Terminated
FDA device recall Z-1174-2013 was initiated by DePuy Mitek, Inc., A Johnson & Johnson Co. on Mar 22, 2013 and is designated Class II. Reason for recall: The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet… The recall status is terminated (terminated Feb 24, 2014). Affected quantity: 206540.
Recall details
- Product Type
- Devices
- Report Date
- May 1, 2013
- Initiation Date
- Mar 22, 2013
- Termination Date
- Feb 24, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 206540
Product description
ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
Reason for recall
The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six
Distribution pattern
Nationwide Distribution.
Code information
ALL from Jan 1 2010 - Corrected IFU implementation date
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1174-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026