AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial H...
FDA Device Recall #Z-0805-2015 — Class II — October 15, 2014
Recall Summary
| Recall Number | Z-0805-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 15, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | American Medical Systems, Inc. |
| Location | Minnetonka, MN |
| Product Type | Devices |
| Quantity | 2,165 |
Product Description
AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting of two stainless steel, curved needle passers. The tip portion of each needle passer is configured to allow for secure placement of the connectors. Each needle passer has a plastic handle attached. The system also contains a sling assembly including one piece of loosely knitted polypropylene mesh, two removable plastic insertion sheaths attached to the mesh, and two connectors attached to the insertion sheaths. The mesh is constructed of polypropylene monofilament. An absorbable tensioning suture is threaded into the length of the mesh to allow for tensioning adjustment of the mesh after placement in the patient is achieved. The plastic covering also affords convenient travel of the mesh through the tissue. The connectors are attached to the tip portions of the Monarc needle passers during the procedure. The loosely knitted polypropylene mesh is intended to remain in the body as a permanent implant. The mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.
Reason for Recall
During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sling System; Model # 720088-01; AdVance" XP Male Sling System; Model # 720163-01; Monarc" C Subfacial Hammock; Model # 72404195; Monarc" + Subfacial Hammock; Model #
Distribution Pattern
Worldwide Distribution-US (nationwide) including DC and Puerto Rico and the countries of AUSTRIA, BELGIUM, CROATIA, CECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, LEBANON, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SLOVENIA, SERBIA, SOUTH AFRICA, SPAIN. SWEDEN, SWITZERLAND, TURKEY, UNITED KINGDOM, CHILE, COLUMBIA, COSTA RICA, HONG KONG, MALAYSIA, MARTINIQUE, NEW ZEALAND, PANAMA, PHILIPPINES, SINGAPORE, THAILAND, VENEZUELA, CANADA, AUSTRALIA.
Lot / Code Information
REF 72404195 Lot/Serial 858296001 to 897413030; REF 72404193 Lot Serial 858292001 to 906172040
Other Recalls from American Medical Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0806-2015 | Class II | AdVance"Male Sling System, REF 720088-01 & AdV... | Oct 15, 2014 |
| Z-0209-2015 | Class II | AMS 700 Series Inflatable Penile Prosthesis Acc... | Oct 10, 2014 |
| Z-1279-2013 | Class II | AMS 800¿ Urinary Control System. The AMS 8... | Mar 1, 2013 |
| Z-1280-2013 | Class II | AMS 800¿ Urinary Control System. The AMS 80... | Mar 1, 2013 |
| Z-0259-2013 | Class II | AMS AdVance" Male Sling System 720088-01 AMS A... | Oct 19, 2012 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.