ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in g
FDA device recall Z-1174-2013 · posted 2013-04-25 · Terminated
Recall details
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- 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
- Action taken
- On March 22, 2013, firm notified consignees of recall via letter. Consignees were informed of the following: 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 weeks after implantation. As Blue and Violet ORTHOCORD free strand sutures share the same IFU, IFU-108147 will be revised. Consignees were requested to confirm the receipt of the letter by March 29, 2013.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- NEW
- Quantity affected
- 206540
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-03-22
- Date posted
- 2013-04-25
- Date terminated
- 2014-02-24
- Location
- Raynham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLUE ORTHOCORD SUTURE (K043298) | Depuy Mitek | 2004-12-10 |