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
Enforcement
- Recall Number
- Z-1716-2024
- Event ID
- 94276
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Zimmer, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 8, 2024
- Initiation Date
- March 20, 2024
- Classification Date
- April 30, 2024
- Address
- 1800 W Center St, Warsaw, IN, 46580-2304, United States
Description
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
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
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
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan.