Zimmer Periarticular Locking Plate recalled for improper screw mating defect
Zimmer, Inc. is recalling the ZPLP Distal Lateral Fibular Plate due to a thread form defect that may prevent locking screws from properly mating with the plate, potentially causing surgical delays or loss of fixation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported injuries or illnesses. The structural defect in an orthopedic implant could result in loss of fixation and require re-operation, meeting the criterion for high-risk products where injury has not yet been reported.
Plain-English summary
This recall involves the ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, left-sided, 8-hole, 132 millimeter sterile implant (Item Number 47-2357-018-08). This device is indicated for temporary internal fixation and stabilization of bone fractures and osteotomies.
The recalled plates have a thread form defect in the locking holes that may prevent locking screws from properly mating with the plate. This improper mating may not be readily recognizable by the user, as the screw may not correctly lock.
The defect could result in delayed surgery or loss of fixation, requiring further intervention. The affected product was distributed worldwide, including throughout the United States and to Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, and Taiwan. Seven lot numbers are affected: 64568169, 64697763, 64697764, 65755769, 65782566, 65782567, and 66233085.
The recalled product
- Product
- ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-08
- Manufacturer
- Zimmer, Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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