Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary int
Summary
The FDA issued a Class II for Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 1 by Zimmer, Inc.. Reason: Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readil.
Details
Source
Device Recall
External ID
Z-2254-2023
Action Date
2023-08-09
Status
Ongoing
Category
device
Product Description
Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. Item Number: 00235710106
Lot/Code Info: Lot Number/UDI: 64254511 /(01)0089024055940(10)64254511; 64296571/(01)0089024055940(10)64296571; 65379087/(01)0089024055940(10)65379087; 65379093/(01)0089024055940(10)65379093; 65379096/(01)0089024055940(10)65379096
Quantity Affected: 75 units
Reason for Recall
Thread form issue of the locking holes in that the locking screws would 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.
Distribution
AR AZ MA ME MO NJ NM NY OR WA Foreign: Brazil China Dominican Republic Korea Netherlamds Taiwan
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-27
Company
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 202 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-2254-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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