Zimmer Periarticular Locking Plate recalled for improper screw mating defect
Zimmer, Inc. is recalling the ZPLP Distal Lateral Fibular Plate due to a thread form defect that may prevent locking screws from properly mating with the plate, potentially causing surgical delays 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: This is an FDA Class II medical device recall with no reported injuries or illnesses. The structural defect in an orthopedic implant could result in loss of fixation and require re-operation, meeting the criterion for high-risk products where injury has not yet been reported.
Plain-English summary
This recall involves the ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, left-sided, 8-hole, 132 millimeter sterile implant (Item Number 47-2357-018-08). This device is indicated for temporary internal fixation and stabilization of bone fractures and osteotomies.
The recalled plates have a thread form defect in the locking holes that may prevent locking screws from properly mating with the plate. This improper mating may not be readily recognizable by the user, as the screw may not correctly lock.
The defect could result in delayed surgery or loss of fixation, requiring further intervention. The affected product was distributed worldwide, including throughout the United States and to Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, and Taiwan. Seven lot numbers are affected: 64568169, 64697763, 64697764, 65755769, 65782566, 65782567, and 66233085.
The recalled product
- Product
- ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-08
- Manufacturer
- Zimmer, Inc.
- Hazard
- loss-of-fixation
- delayed-surgery
- improper-screw-mating
Distribution
Distributed nationwide across the United States.
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