Zimmer Fibular Plate Recall: Locking Hole Thread Form Defect
Zimmer is recalling certain ZPLP Distal Lateral Fibular Plates due to a thread form issue in the locking holes. Improperly mating screws may not correctly lock, potentially resulting in loss of fixation and need for additional surgery.
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 an FDA Class II recall of a surgical implant with a concrete mechanical defect that could result in loss of fixation requiring additional surgery. No illnesses or injuries have been reported. The hazard is established but harm remains potential, meeting Score 3 criteria: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling certain ZPLP Distal Lateral Fibular Plates (Item Number 00-2357-018-08) used for temporary internal fixation and stabilization of bone fractures and osteotomies. The recall affects specific lot numbers and has worldwide distribution including the United States, Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, South Korea, Singapore, Switzerland, and Taiwan.
The products are being recalled due to a thread form issue in the locking holes. This defect may prevent locking screws from properly mating with the plate and locking securely.
When a screw fails to properly lock, the defect may not be immediately obvious to the surgeon, as the screw may appear to be seated when it is not. This improperly mated screw may result in loss of fixation of the plate and bone fragments, which could lead to delay in surgery or require additional surgical intervention.
Patients and healthcare providers who have received implants from affected lots should contact Zimmer, Inc. for further guidance. Healthcare providers should review their inventory and check the lot numbers against the affected list provided by the manufacturer.
The recalled product
- Product
- ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-08
- 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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