Recall Z-1699-2015 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Zimmer, Inc.
M/L Taper with Kinectiv Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenit
| Date | Jun 8, 2015 (initiated May 18, 2015) |
| Status | Terminated |
| Reason | Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv femoral stems and modular necks due higher than allowed cytotoxicity levels found with the product. Reasonable probability of adverse biological response and subsequent revision |
| Root cause | Environmental control |
| Action | Zimmer, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated May 18, 2015, to all affected consignees. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate all affected product identified and quarantine them immediately. Carry out a physical count of all affected product in their inventory and complete the Inventory Return Certification F |
| Quantity | 752 |
| Distribution | Worldwide Distribution - US Nationwide in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OK, PA, TX, UT, VA, WA, WI and countries of Canada, Australia, Japan, Taiwan, France, Germany, Spain, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071856 | ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES Zimmer, Inc., Jul 30, 2007 |