MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamp...
FDA Device Recall #Z-0559-2013 — Class II — November 5, 2012
Recall Summary
| Recall Number | Z-0559-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 5, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Integra LifeSciences Corporation |
| Location | Cincinnati, OH |
| Product Type | Devices |
| Quantity | eight (8) skull clamps were distributed |
Product Description
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
Reason for Recall
An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d
Distribution Pattern
Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA TN, TX, UT, VA, WA and WI.
Lot / Code Information
The recalled product is identified with the Lot Numbers: 096455 and 097546.
Other Recalls from Integra LifeSciences Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2777-2016 | Class II | Integra Meshed Dermal Regeneration Template 5 c... | Mar 11, 2016 |
| Z-1084-2015 | Class II | The MAYFIELD¿ Ultra 360 Base Unit for head posi... | Dec 19, 2014 |
| Z-1697-2014 | Class II | Integra Newdeal SURFIX Fixed Angle Locking Scre... | Mar 28, 2014 |
| Z-1736-2013 | Class II | Integra PANTA Arthrodesis Nail System. Inten... | May 9, 2013 |
| Z-1297-2013 | Class II | Ora Plug Absorbable Collagen Wound Dressing for... | Mar 28, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.