Scottsdale, AZ, United States
Cayenne Medical Inc. recalls
3 recalls recorded since 2018, most recently on 10 October 2013. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 October 2013
- Terminated
- 26 February 2019
- Reason
- A review of complaints identified a trend for drills breaking.
- Distribution
- US distribution to AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2571-2018
- Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324
Terminated Class II Medical devices
- Recall started
- 11 July 2013
- Terminated
- 14 September 2018
- Reason
- Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 use in ligament reconstruction.
Terminated Class II Medical devices
- Recall started
- 28 April 2010
- Terminated
- 26 February 2019
- Reason
- A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.
- Distribution
- Worldwide distribution. US nationwide, Denmark, Finland, Malaysia, Netherlands, Poland, Switzerland, and Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2548-2018
- AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Remov
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.