Zimmer Periarticular Locking Plate screw-mating defect risks surgical fixation loss
Zimmer's Periarticular Locking Plate System has a thread defect that may prevent proper screw locking, potentially causing loss of surgical fixation. Affected units distributed worldwide.
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 manufacturing defect in an FDA Class II surgical implant that could result in loss of fixation and need for further surgical intervention. However, the source text does not report any injuries or hospitalizations, so the score does not exceed High per the rubric.
Plain-English summary
Zimmer, Inc. is recalling the ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile (Item Number 47-2357-017-12) due to a manufacturing defect in the locking holes.
The thread form issue in the locking holes may prevent locking screws from properly mating with the plate. This defect may not be readily recognizable during use, as a screw may appear to lock when it does not. When not properly locked, the plate may lose fixation.
Loss of fixation may result in delay during surgery or require further surgical intervention. The affected product is distributed worldwide, including throughout the United States and in Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, South Korea, Singapore, Switzerland, and Taiwan.
Healthcare facilities and surgeons should discontinue use of affected lot numbers (64475610, 65038408, 65038409, 65209412, 65209413) and contact Zimmer, Inc. for instructions on product return or replacement.
The recalled product
- Product
- ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-12
- 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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