Agency classClass IIOur severity:High FDA (Devices)·Z-1715-2024·Announced 2024-05-08

Zimmer Distal Lateral Fibular Plate may fail to lock properly

Zimmer orthopedic plates may have thread defects preventing locking screws from properly mating, 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: FDA Class II medical device recall involving a manufacturing defect in locking mechanisms that could result in loss of surgical fixation requiring re-operation. No injuries or hospitalizations have been reported; the hazard is potential rather than actualized, meeting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Zimmer, Inc. has recalled ZPLP Distal Lateral Fibular Plates (Item Number 7-2357-018-04) used in orthopedic surgery. The affected lots contain a thread form defect in the locking holes that may prevent locking screws from properly mating with the plate.

An improperly mated screw may not lock correctly, and this defect may not be immediately recognizable to the surgeon. This could result in loss of fixation during surgery, potentially requiring additional surgical intervention.

Affected units have been distributed worldwide, including to the United States, Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, South Korea, Singapore, Switzerland, and Taiwan. The 14 affected lot numbers are detailed in the recall notice.

Healthcare providers should verify whether devices in their inventory match the affected lot numbers and discontinue use of affected units. Patients who have received this implant should contact their surgeon if they experience complications.

The recalled product

Product: ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 7-2357-018-04
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: fixation-loss
screw-locking-defect

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 · fixation loss