Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic ...
FDA Device Recall #Z-0644-2013 — Class II — November 5, 2012
Recall Summary
| Recall Number | Z-0644-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 5, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Applied Medical Resources Corp |
| Location | Rancho Santa Margarita, CA |
| Product Type | Devices |
| Quantity | 72 units |
Product Description
Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
Reason for Recall
Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and France.
Lot / Code Information
Lot Number: 1179107
Other Recalls from Applied Medical Resources Corp
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1010-2026 | Class II | Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55... | Dec 11, 2025 |
| Z-1388-2024 | Class II | Epix Universal Clip Applier, REF: CA500, STERILEEO | Jan 30, 2024 |
| Z-1389-2024 | Class II | Epix Universal Clip Applier, REF: CA500, STERIL... | Jan 30, 2024 |
| Z-2160-2020 | Class II | DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)3... | Mar 17, 2020 |
| Z-2161-2020 | Class II | Clip Applier Kit, REF: K2887, UDI: (01)30607915... | Mar 17, 2020 |
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.