Class II Recall

ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and sta

Summary

The FDA issued a Class II for ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated by Zimmer, Inc.. 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.

Details

Source

Device Recall

External ID

Z-1724-2024

Action Date

2024-05-08

Status

Ongoing

Product Description

ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-08

Lot/Code Info: GTIN: 00889024055889 Lot Numbers: 64475412 64475418 64475422 64475426 64475427 64475428 64475431 64475435 64475439 64475443 64475444 64475445 64475446 64475447 64475448 64475449 64475450 64482031 64482032 64482033 64482034 64482035 64482042 64482043 64482044 64482045 64482046 64482047 64482048 64482051 64482052 64482057 64528508 64528509 64629014 64629015 64629017 64629018 64629019 64629020 64629022 64629023 64629024 64629025 64660057 64660060 64660063 64660066 64660067 64800086 64800087 64800088 64800089 64800090 64800091 64811207 64811208 64811209 64811210 64811212 64811213 64811214 64811215 65060838 65060839 65060840 65060841 65060842 65060843 65060844 65060845 65060846 65060847 65060848 65060849 65060850 65060851 65060852 65060853 65060854 65060855 65074872 65074873 65074874 65074875 65074876 65074877 65192591 65192592 65192593 65192594 65192595 65192596 65192597 65192598 65192599 65192601 65192602 65192603 65229326 65229327 65229328 65229332 65229337 65229341 65229344 65229348 65328548 65537763 65537767 65537771 66108602 66108605 66240694

Reason for Recall

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

Distribution

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

Type: Voluntary: Firm initiated

Recall Initiated: 2024-03-20

Company

Zimmer, Inc.

Warsaw, IN

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 175 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Zimmer, Inc. has 87 FDA actions in our database, including 65 recalls and 22 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zimmer, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Zimmer, Inc. have FDA actions?

Zimmer, Inc. has 87 FDA actions in our database, including 65 recalls and 22 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1724-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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