STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control… — Class II medical device recall Z-1533-2024
Ongoing recall by Ethicon, Inc., reported 2024-04-24, distributed in CO, GA, IA, MI, NJ, NY, PA, SC…. Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit
| Recall number | Z-1533-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Raritan, NJ, United States |
| Recall initiated | 2024-03-08 |
| Classified | 2024-04-12 |
| Reported by FDA | 2024-04-24 |
| Distributed | CO, GA, IA, MI, NJ, NY, PA, SC, WI |
| Quantity | 395 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10705031464285, 30705031464289 |
| Expiration dates | 2024-06-30 |
Product
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
Reason for recall
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
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-1533-2024. 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.