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High RiskFDAfda-Z-2227-2017FALL HAZARD

Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software bas...

Units Affected
10
Recall Date
June 4, 2008
Issuing Agency
Hazard
Fall Hazard

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2227-2017.

Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2227-2017.

Recall terminated by FDA.

🩺 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-2227-2017.

Orthosoft, Inc. dba Zimmer CAS

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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Orthosoft, Inc. Dba Zimmer Cas Recall FAQ

Orthosoft, Inc. Dba Zimmer Cas is the subject of a medical devices safety report: Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software bas.... The notice was published on June 4, 2008 by the U.S. Food and Drug Administration (FDA). Approximately 10 units are potentially affected.