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Recall Observatory FDA recall evidence

Device product

ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-06

Z-1716-2024

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-1716-2024

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)00889024088573(17)290510(10)64370380 (01)00889024088573(17)290517(10)64370382 (01)00889024088573(17)290607(10)64423329 (01)00889024088573(17)290811(10)64475643 (01)00889024088573(17)300225(10)64661551 (01)00889024088573(17)300307(10)64661552 (01)00889024088573(17)300511(10)64745739 (01)00889024088573(17)300506(10)64745742 (01)00889024088573(17)300506(10)64745744 (01)00889024088573(17)300506(10)64745745 (01)00889024088573(17)321209(10)65635924 (01)00889024088573(17)321207(10)65645147 (01)00889024088573(17)330215(10)65755766 (01)00889024088573(17)330430(10)65997131 (01)00889024088573(17)330428(10)65997134 (01)00889024088573(17)330430(10)66023658 (01)00889024088573(17)330730(10)66166098 (01)00889024088573(17)330811(10)66201200 (01)00889024088573(17)330822(10)66233083 (01)00889024088573(17)330822(10)66233084 Lot Numbers: 64370380 64370382 64423329 64475643 64661551 64661552 64745739 64745742 64745744 64745745 65635924 65645147 65755766 65997131 65997134 66023658 66166098 66201200 66233083 66233084

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