DePuy Mitek Recalls ORTHOCORD Sutures Due to Inaccurate Strength Labeling
DePuy Mitek is recalling ORTHOCORD sutures because the instructions for use incorrectly state that Blue sutures retain 100% strength at six weeks.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling error regarding suture strength retention. No injuries or illnesses are reported, and the hazard is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code 223115. The recall involves 46,732 units distributed nationwide.
The recall is due to an inaccuracy in the Instructions for Use (IFU) provided with the free strand ORTHOCORD sutures. The IFU states that approximately 100% suture strength remains at six weeks after implantation. While this statement is accurate for Violet ORTHOCORD sutures, it is inaccurate for Blue ORTHOCORD free strand sutures, which maintain approximately 80% of strength at six weeks based on in-vivo strength retention studies.
The recall covers all units from January 1, 2010, to the corrected IFU implementation date. Healthcare providers and facilities should stop using the affected Blue ORTHOCORD sutures and contact DePuy Mitek for instructions on returning the product.
The recalled product
- Product
- ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- Affected units
- 46,732
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 (1)
- ALL from Jan 1 2010 - Corrected IFU implementation date
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. 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.
See all 5 products in this recall →Related recalls
Same manufacturer · DePuy Mitek, Inc., a Johnson & Johnson Co.
See all →- HighCOR Disposable Cartilage Transplant Kit recalled for missing graft loader pin
FDA (Devices) · 2025-03-19
- HighCartilage Transplant System Disposable Kits Recalled for Missing Component
FDA (Devices) · 2025-03-19
- HighSurgical Anchor Inserter Tip Fragmentation During Patient Procedures
FDA (Devices) · 2023-06-14
- HighDePuy Mitek surgical anchor inserter may fracture during use
FDA (Devices) · 2023-06-14
- HighSurgical anchor inserter recalled for potential tip fracture and bone damage
FDA (Devices) · 2023-06-14
Same hazard · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02