AMS Monarc Subfascial Hammock Kits Recalled for Packaging Integrity Concerns
American Medical Systems is recalling Monarc + and Monarc C Subfascial Hammock kits because routine testing showed the sterile packaging might fail during extreme shipping.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential loss of sterility in a medical device intended for implantation, which poses a risk of harm even though no specific injuries are reported in the text.
Plain-English summary
American Medical Systems, Inc. is recalling the AMS Monarc + Subfascial Hammock with Tensioning Suture (REF 72404193) and the AMS Monarc C Subfascial Hammock with Tensioning Suture (REF 72404195). These are sterile, single-use procedure kits containing stainless steel needle passers, a polypropylene mesh sling assembly, and an absorbable tensioning suture. The mesh is intended to remain in the body as a permanent implant.
The recall was initiated after routine periodic packaging testing revealed that the sterile barrier packaging of the Needle Passer components could fail in simulated extreme shipping and handling situations. This potential failure could compromise the sterility of the components. The agency has classified this as a Class II recall.
A total of 2,165 units were distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international locations such as Canada, Australia, and various countries in Europe, Asia, and South America. Affected lot serial numbers for REF 72404195 range from 858296001 to 897413030, and for REF 72404193 range from 858292001 to 906172040. Healthcare providers and patients should contact American Medical Systems for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- 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…
- Manufacturer
- American Medical Systems, Inc.
- Affected units
- 2,165
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- REF 72404195 Lot/Serial 858296001 to 897413030
- REF 72404193 Lot Serial 858292001 to 906172040
Distribution
Part of a larger recall action
This product is one of 2 recalled by American Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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