Zimmer Periarticular Locking Plate May Fail to Secure Fracture Fixation
Zimmer's periarticular locking plates may fail to properly secure surgical fixation due to a thread-form defect. The defect could result in loss of fixation requiring further surgical intervention.
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: FDA Class II device with a defect that may result in loss of surgical fixation requiring further intervention. No injuries or hospitalizations have been reported; this is a risk-of-harm product where potential for patient harm exists but has not yet manifested.
Plain-English summary
Zimmer, Inc. is recalling specific lots of its ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plates due to a thread-form defect affecting the locking holes.
The defect may prevent locking screws from properly mating with the plate. Users may not immediately recognize the defect because the screw may appear to lock even though it has not properly engaged.
Affected surgeons should verify proper screw locking before completing fracture-fixation procedures. If improper locking is detected, the affected plate should not be used. Loss of fixation may result in delayed healing or require revision surgery.
Patients who have received these plates should contact their healthcare provider if they experience unexpected surgical complications. The recall affects worldwide distribution including 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, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-16
- 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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Same hazard · thread defect
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