Zimmer Periarticular Locking Plate System Screw-Locking Defect Recall
Zimmer is recalling Periarticular Locking Plate System Distal Lateral Fibular Plates due to threading defects that may prevent locking screws from properly mating. This could result in loss of fixation and need for additional surgery.
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 a medical device with a manufacturing defect that creates risk of surgical complications requiring further intervention. The source does not mention any reported injuries. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling the ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate. This surgical implant is used for internal fixation and stabilization of bone fractures and osteotomies.
The recall is due to a thread form issue in the locking holes. The locking screws may not properly mate with the plate. Because the improper mating may not be readily apparent, a surgeon might not recognize that the screw has not properly locked.
If the screw does not properly lock, the plate may lose fixation, requiring additional surgical intervention. The source indicates this could result in surgical delays or loss of fixation.
The affected devices were distributed worldwide, including throughout the United States, Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, South Korea, Singapore, Switzerland, and Taiwan.
The recalled product
- Product
- ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-12
- 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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