Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2543-2014·Announced 2014-09-03

Zimmer Persona Distal Valgus Alignment Guide Recalled for Mechanical Defect

Zimmer, Inc. is recalling 2,248 units of the Persona Distal Valgus Alignment Guide because the collet locks are seizing in the unlocked position.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a mechanical defect (seizing locks) without reporting any specific injuries, illnesses, or deaths. This aligns with the 'Moderate' severity criteria for low-risk contamination or voluntary precautionary recalls where harm has not been reported.

Plain-English summary

Zimmer, Inc. is recalling 2,248 units of the Persona Distal Valgus Alignment Guide, a nonsterile orthopedic surgical instrument. The device is used to set the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.

The recall is due to a mechanical defect where the collet locks are seizing in the 'unlocked' position. This issue could potentially interfere with the proper function of the instrument during surgical procedures.

The affected units were distributed worldwide, including the United States (including Puerto Rico), Australia, Austria, Japan, Belgium, Italy, Switzerland, India, Germany, Spain, France, Israel, Netherlands, Saudi Arabia, South Africa, and Canada. Healthcare facilities and distributors should stop using the affected devices and contact Zimmer, Inc. for instructions on return or replacement.

The recalled product

Product: Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Surgical Instrument
Hazard: mechanical-defect
Affected units: 2,248

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 (20)

Item Number 42509900400
Lot Number: 62313324
62415340
62561031
62668655
62313326
62430425
62580270
62695918
62341561
62442314
62590506
62702686
62358628
62473246
62594059
62715932
62368700
62507846
62611157

Distribution

Distributed in 1 state:

Same manufacturer · Zimmer, Inc.

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