Zimmer Periarticular Locking Plate System recalled due to faulty screw threads
Zimmer recalls Periarticular Locking Plate System devices due to thread defects that may prevent proper screw locking and cause surgical delay or loss of fixation.
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: FDA Class II device recall for a real manufacturing defect affecting a high-risk surgical implant. The thread form defect prevents proper screw locking, which can result in loss of fixation—a serious consequence in orthopedic surgery. No illnesses or injuries have been reported, consistent with a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer Inc. is recalling certain Distal Lateral Fibular Plates from its Periarticular Locking Plate System (ZPLP) due to thread form defects in the locking holes. The defect may prevent locking screws from properly mating with and locking into the plate. Improperly locked screws may not be readily recognizable by the user.
If not properly locked, the fixation may be lost or surgery may be delayed, each requiring further intervention. The affected lot numbers are 65588868, 65943457, and 66034781. These devices were distributed worldwide, 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, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-10
- Manufacturer
- Zimmer, Inc.
- Hazard
- thread-defect
- locking-failure
- loss-of-fixation
Distribution
Distributed nationwide across the United States.
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