Agency classClass IIOur severity:High FDA (Devices)·Z-1729-2024·Announced 2024-05-08

Zimmer Distal Lateral Fibular Plate Recall Due to Locking Thread Defect

Zimmer recalls certain ZPLP Distal Lateral Fibular Plates due to thread form defects in locking holes that may prevent proper screw fixation. Affected devices may lose fixation, potentially delaying surgery or requiring additional intervention.

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: FDA Class II medical device recall with no reported adverse events, injuries, or hospitalizations. The hazard is mechanical failure of a critical surgical fixation mechanism where locking screws may not properly mate with the plate, risking loss of fixation and need for re-surgery. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

Zimmer, Inc. is recalling specific lots of the ZPLP Distal Lateral Fibular Plate (Item Number 00-2357-018-10), a medical device used for temporary internal fixation and stabilization of bone fractures and osteotomies. The recalled lots are distributed worldwide, including throughout the United States and in 13 additional countries.

The devices are subject to recall due to a thread form issue in the locking holes. This defect may prevent locking screws from properly mating with the plate. Because the screw may not correctly lock, the defect may not be readily recognizable during surgical use, and loss of fixation can occur.

When proper fixation is lost, delayed surgery or the need for further intervention and re-operation may result. Healthcare facilities should verify the lot numbers of their inventory against the recall list and consult with Zimmer regarding alternatives or corrective measures.

The recalled product

Product: ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-10
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: thread-defect
loss-of-fixation

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.

See all 21 products in this recall →

Same manufacturer · Zimmer, Inc.

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Same hazard · thread defect