The Recall Desk
HighFDA (Devices)·Z-2422-2018·Announced 2018-07-18

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.

What this means for you

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.
Category
Medical Device — Orthopedic Implant
Hazard
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.

Related recalls

Same manufacturer · Cayenne Medical Inc.

See all →

Same hazard · structural failure

See all →