Zimmer Distal Lateral Fibular Plate may fail to lock screws securely
Zimmer's Distal Lateral Fibular Plate has threading defects that may prevent screws from locking properly. The defect could go unnoticed during surgery and cause loss of fixation.
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 risk-of-harm medical device where potential serious injury has not yet been reported. The defect is confirmed (thread form issue), but no illnesses or injuries have been documented, making the hazard theoretical. FDA Class II designation combined with no reported patient harm supports a High severity rating.
Plain-English summary
Zimmer, Inc. is recalling specific lot numbers of the ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM (Item Number 47-2357-017-04). This surgical implant is used for temporary internal fixation and stabilization of bone fractures and osteotomies.
The affected plates have a thread form defect in the locking holes that may prevent locking screws from properly mating with the plate. Because the improper fit may not be readily apparent to the surgeon during the procedure, an improperly locked screw might not be detected during surgery. This could result in surgical delay or loss of fixation, potentially requiring additional intervention.
The recalled product has been distributed worldwide, including throughout the United States and internationally to Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, South Korea, Singapore, Switzerland, and Taiwan. Eight specific lot numbers are affected, identified by their UDI codes. Healthcare facilities should check their inventory against these lot numbers.
The recalled product
- Product
- ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-04
- 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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