MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone materia...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0762-2014.
The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decide
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0762-2014.
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:
- Do not stop, change, or discard your prescription on your own.
- 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).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- 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-0762-2014.
The Anspach Effort, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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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.
The Anspach Effort, Inc. Recall FAQ
The Anspach Effort, Inc. is the subject of a medical devices safety report: MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone materia.... The notice was published on March 29, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 6,439 units are potentially affected.