Recall Z-1711-2024 ยท HWC Screw, Fixation, Bone
Zimmer, Inc.
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-08
| Date | Apr 30, 2024 (initiated Mar 20, 2024) |
| Status | Open, Classified |
| Reason | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention |
| Root cause | Under Investigation by firm |
| Action | Zimmer issued Urgent Medical Device Recall Letter to Distributors Risk Managers and Surgeons on March 20, 2024 via mail/email. Letter states reason for recall, health risk and action to take: Our records indicate that you may have received one or more of the affected products. The affected units were distributed between March 2019 and January 2024. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected pro |
| Distribution | Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070906 | MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS Zimmer, Inc., May 1, 2007 |