ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6… — Class II medical device recall Z-1176-2013
Terminated recall by DePuy Mitek, Inc., a Johnson & Johnson Co., reported 2013-05-01, distributed nationwide. The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture str
| Recall number | Z-1176-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, United States |
| Recall initiated | 2013-03-22 |
| Classified | 2013-04-25 |
| Reported by FDA | 2013-05-01 |
| Terminated | 2014-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 46,501 |
| Reason classes | potency |
Product
ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1176-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.