Recall Z-1608-2024 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer, Inc.
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
| Date | Apr 22, 2024 (initiated Mar 28, 2024) |
| Status | Open, Classified |
| Reason | Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate. |
| Root cause | Process change control |
| Action | Consignees were sent an URGENT MEDICAL DEVICE RECALL notification dated 3/28/24. Distributors are to review the provided notification, notify the appropriate team members of the contents of the notification, locate and quarantine affected product in your inventory, return all affected product from the respective distributorship and affected hospitals to Zimmer by submitting an Inventory Return Certification Form to CorporateQuality.PostMarket@zimmerbiomet.com (international returns are to be coordinated by emailing zimmerbiometintlirarequests@zimmerbiomet.com), and retain a copy of the Invento |
| Quantity | 5,546 units |
| Distribution | Worldwide distribution - US Nationwide including the states of AK, AL, CA, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the countries of Australia, Canada, Japan, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031061 | NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS Zimmer, Inc., Oct 9, 2003 |