Agency classClass IIOur severity:High FDA (Devices)·Z-1725-2024·Announced 2024-05-08

ZPLP Distal Lateral Fibular Plates Recalled for Defective Threading

Zimmer surgical plates may have thread defects that prevent screws from properly locking, potentially causing loss of surgical fixation. Affected devices were distributed worldwide; healthcare providers should verify lot numbers against the FDA recall notice.

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 for a structural defect in an orthopedic surgical device that could cause loss of surgical fixation, representing a risk of harm. No hospitalizations or injuries have been reported, meeting the rubric criterion for High severity.

Plain-English summary

Zimmer, Inc. is recalling specific lots of the ZPLP Distal Lateral Fibular Plate (Item Number 00-2357-017-10), a surgical device used for temporary internal fixation of bone fractures and osteotomies. The device has a thread form issue affecting the locking holes.

The defect may prevent locking screws from properly mating with the plate. Because the improper fit may not be readily apparent to the user, the screw may appear locked when it is not. This could result in loss of fixation, potentially causing delays in surgery or requiring additional surgical intervention.

The affected devices were distributed worldwide, including throughout the United States and to Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Korea, Singapore, Switzerland, and Taiwan. The recall affects multiple specific lot numbers.

Individuals and healthcare providers with these devices should refer to the FDA's official recall announcement for a complete list of affected lot numbers and instructions regarding affected devices.

The recalled product

Product: ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-10
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Surgical Fixation
Hazard: thread-defect
screw-locking-failure
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