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.
What this means for you
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.
- Hazard
- manufacturing-defect
- loss-of-fixation
- improper-screw-locking
Distribution
Distributed nationwide across the United States.
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