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Medacta Usa Inc FDA Recalls
9 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.Class IIApr 30, 2026Surgical instruments used during shoulder arthroplasty proce |
| MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion deviceClass IIMar 8, 2023There is a potential for breakage of the small screw used to |
| MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion deviceClass IIMar 8, 2023There is a potential for breakage of the small screw used to |
| MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion deviceClass IIMar 8, 2023There is a potential for breakage of the small screw used to |
| MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion deviceClass IIMar 8, 2023There is a potential for breakage of the small screw used to |
| MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion deviceClass IIMar 8, 2023There is a potential for breakage of the small screw used to |
| MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion deviceClass IIMar 8, 2023There is a potential for breakage of the small screw used to |
| NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platforClass IIOct 27, 2022A warning has been added to the Surgical Technique for NextA |
| GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1Class IIApr 13, 2022A Size 2 trial baseplate was assembled with Size 1 instrumen |