Zimmer Periarticular Locking Plate recalled due to thread form defect
Zimmer Periarticular Locking Plates have a thread form defect that prevents surgical screws from properly mating with the plate. 75 units distributed across multiple U.S. states and internationally.
What this means for you
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 FDA Class II recall involves a risk-of-harm medical implant where a thread defect could compromise surgical fixation. No hospitalizations or injuries have been reported, meeting the rubric criterion for risk-of-harm products without reported adverse events.
Plain-English summary
Zimmer, Inc. is recalling 75 units of the Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate, a medical device used for temporary internal fixation and stabilization of bone fractures and osteotomies.
The recalled plates have a thread form defect in the locking holes that prevents locking screws from properly mating with the plate. This improper mating may not be readily recognizable by the surgeon or medical staff, creating a risk that the fixation will not be secure.
Affected units were distributed to healthcare facilities in Arkansas, Arizona, Massachusetts, Maine, Missouri, New Jersey, New Mexico, New York, Oregon, and Washington, as well as to Brazil, China, Dominican Republic, Korea, Netherlands, and Taiwan. The affected lot numbers are 64254511, 64296571, 65379087, 65379093, and 65379096.
Healthcare providers and surgeons should immediately cease use of affected units and contact Zimmer, Inc. for replacement or return instructions.
The recalled product
- Product
- Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular cond
- Manufacturer
- Zimmer, Inc.
- Affected units
- 75
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Number/UDI: 64254511 /(01)0089024055940(10)64254511
- 64296571/(01)0089024055940(10)64296571
- 65379087/(01)0089024055940(10)65379087
- 65379093/(01)0089024055940(10)65379093
- 65379096/(01)0089024055940(10)65379096
Distribution
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