← Every firm
Spineart SA FDA Recalls
5 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Class IIJun 30, 2025Cannulated fenestrated polyaxial screws may be incorrectly l |
| Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Class IIJun 30, 2025Cannulated fenestrated polyaxial screws may be incorrectly l |
| PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-Class IIMar 15, 2024Due to receiving information regarding difficulties with the |
| JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JClass IIMar 16, 2023JULIET Lateral Lumbar Ti-Life Plate, a component of the JULI |
| PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle Class IIApr 9, 2021Due to external labelling error/mix-up. Affected product ex |