Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device… — Class II medical device recall Z-0458-2014
Terminated recall by Ethicon, Inc., reported 2013-12-18, distributed nationwide. Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fas
| Recall number | Z-0458-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2013-09-25 |
| Classified | 2013-12-06 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2016-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, MY, SG |
| Quantity | 37,164 eaches |
Product
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
Reason for recall
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
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-0458-2014. 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.