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High RiskFDAfda-Z-1400-2023OTHER

MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device

Units Affected
32
Recall Date
March 8, 2023
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1400-2023.

There is a potential for breakage of the small screw used to affix the anti-backout plate.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1400-2023.

Recall ongoing. Follow firm instructions.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1400-2023.

Medacta Usa Inc

FDA

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📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

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Medacta Usa Inc Recall FAQ

Medacta Usa Inc is the subject of a medical devices safety report: MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device. The notice was published on March 8, 2023 by the U.S. Food and Drug Administration (FDA). Approximately 32 units are potentially affected.