Cayenne Medical Recalls AperFix AM Femoral Implants Due to Breakage Risk
Cayenne Medical Inc. is recalling 976 units of AperFix AM Femoral Implants because they may break inside the femoral socket during orthopedic use.
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 involves a structural defect (implant breakage) in a medical device where no injuries or illnesses have been reported, fitting the criteria for a high-risk product where harm has not yet been documented.
Plain-English summary
Cayenne Medical Inc. is recalling 976 units of the AperFix AM Femoral Implant, specifically model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). These medical devices are intended for orthopedic use in ligament reconstruction. The recall was initiated due to a potential for the 24 mm implant to break inside the drilled femoral socket.
The affected units were distributed nationwide in the United States. The specific lot numbers involved are CM-2409 (40731-2, 40743-5, 41049-1, 41237-2, 41536-2, 41737-2, 42219-2) and CM-2410 (40731-3, 40743-6, 41049-2, 41237-3, 41536-3, 41737-3, 42219-3). The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare providers and patients who have used these implants should contact Cayenne Medical Inc. for further instructions on how to proceed. The U.S. Food and Drug Administration has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.
- Manufacturer
- Cayenne Medical Inc.
- Affected units
- 976
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 (14)
- Item Number (Lot Number): CM-2409 (40731-2
- 40743-5
- 41049-1
- 41237-2
- 41536-2
- 41737-2
- 42219-2)
- CM-2410 (40731-3
- 40743-6
- 41049-2
- 41237-3
- 41536-3
- 41737-3
- 42219-3).
Distribution
Distributed nationwide across the United States.
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