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.
What this means for you
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.
- Hazard
- 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:
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