MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed...
FDA Device Recall #Z-1092-2015 - Class II, December 17, 2014
Recall Summary
| Recall Number | Z-1092-2015 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 17, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Craniomaxillofacial Division |
| Location | Portage, MI |
| Product Type | Devices |
| Quantity | 1051 |
Product Description
MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
Reason for Recall
Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of PA, KY, VA, CT, UT, MD, AR, FL, TX, AL, DE, IL, IA, MI, CO, OH, GA, CA, DC, MO, LA, WI, ID, SC, NC, NY, MA, NH, CA, OK, MN, KY, IN, OR, TN and the countries of: Argentina, Australia, Canada, Chile, China, Netherlands, France, Spain, South Korea, Colombia, Switzerland, Singapore, and South Africa.
Lot / Code Information
Part Number 9312; Lot Number A1403008
Other Recalls from Stryker Craniomaxillofacial Division
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0114-2016 | Class II | Disposable Paper Filter for Sterilization Conta... | Sep 17, 2015 |
| Z-1091-2015 | Class II | MEDPOR BARRIER Sheets Orbital Floor Implant ... | Dec 17, 2014 |
| Z-1090-2015 | Class II | MEDPOR Surgical Implant Contoured Two Piece Chi... | Dec 17, 2014 |
| Z-1093-2015 | Class II | MEDPOR TITAN MAX Orbital Floor and Wall (OFW) M... | Dec 17, 2014 |
| Z-2054-2013 | Class II | Stryker Part Numbers 79-43903 (3cc), 79-43905 (... | Jul 30, 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.