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Recall Observatory FDA recall evidence

Device product

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

Z-1715-2024

March 20, 2024

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 94276
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1715-2024

Official wording

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

Code information: 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

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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