Z-2422-2018Class II

AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic...

Name: Z-2422-2018 AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic...
Creator: Cayenne Medical Inc.
Published: 2013-07-11
License: https://open.fda.gov/license/

Cayenne Medical Inc. / initiated 2013-07-11 / Terminated / root cause: design

FDA source

Cayenne Medical Inc. began a recall of 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 on 2013-07-11. FDA classified it as Class II and gives the reason as "Potential for AperFix 24 mm implant breaking inside the drilled femoral socket". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2422-2018
Classification: Class II
Status: Terminated
Initiated: 2013-07-11
Posted: 2018-07-10
Terminated: 2018-09-14
Recalling firm: Cayenne Medical Inc.
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.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.
Root cause tag: design
FDA root cause: Device Design
Action: Customers were contacted on approximately 07/11/2013 and were instructed to return any affected products on hand.
Quantity in commerce: 976 units
Distribution: US nationwide distribution.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2422-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2422-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10

Product code HWC

K083612Class IIAperfix Femoral Implant with Inserter, 9,10,11 Mm X 35Mm and X 29MmCayenne Medical, Inc. / cleared 2009-03-04

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)