Class II — Ethicon, Inc.
| Recalling firm | ETHICON INC. |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility |
| 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 |
| Quantity | 395 units |
| Distribution | CO GA IA MI NJ NY NY PA SC WI |
| Initiated | 2024-03-08 |
| Classified | 2024-04-12 |
| Recall number | Z-1533-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ethicon, Inc. (Z-1533-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94220/
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