FDAFDA · Food and drugs·Recall number Z-1715-2024
ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 7-2357-018-04
Published May 8, 2024 · Recall initiated: March 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan.
- Lot
- UDI: (01)00889024088566(17)290409(10)64325922 (01)00889024088566(17)290414(10)64325923 (01)00889024088566(17)290515(10)64396817 (01)00889024088566(17)290517(10)64396818 (01)00889024088566(17)290831(10)64464677 (01)00889024088566(17)300325(10)64714915 (01)00889024088566(17)300330(10)64714916 (01)00889024088566(17)300321(10)64714917 (01)00889024088566(17)320329(10)65324701 (01)00889024088566(17)320510(10)65387353 (01)00889024088566(17)330220(10)65716463 (01)00889024088566(17)330127(10)65716464 (01)00889024088566(17)330426(10)65982902 (01)00889024088566(17)330426(10)66010705 Lot Numbers: 64325922 64325923 64396817 64396818 64464677 64714915 64714916 64714917 65324701 65387353 65716463 65716464 65982902 66010705
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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