Facility
Johnson & Johnson do Brasil Ind. Com. de Prod. p/ Saude Ltda
5 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3004903580 |
|---|---|
| Establishment type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | RODOVIA PRESIDENTE DUTRA SAO JOSE DOS CAMPOS Sao Paulo, BR 12240 |
| Registration status | Active · expires 2026 |
| Parent company | ETHICON INC. (owner-operator 9068641) |
| Brand names | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device; STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device |
Devices registered here (1)
- Suture, Nonabsorbable, Synthetic, PolypropyleneProduct code GAW · Class II · General, Plastic Surgery · 21 CFR 878.5010
Recalls & enforcement
- Class IIOngoing2024-10-08Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
- Class IIOngoing2024-09-25Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
- Class IIOngoing2024-05-10Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Class IIOngoing2024-03-08Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
- Class IIOngoing2023-03-31Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
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