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Recall Observatory FDA recall evidence

Device 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.

Z-2543-2014

July 30, 2014

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 68801
Status
Terminated
Classification
Class II
Quantity
2,248 units
Official record key
device-enforcement:Z-2543-2014

Official wording

Reason: Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position.

Code information: Item Number 42509900400, Lot Number: 62313324, 62415340, 62561031, 62668655, 62313326, 62430425, 62580270, 62695918, 62341561, 62442314, 62590506, 62702686, 62358628, 62473246, 62594059, 62715932, 62368700, 62507846, 62611157, 62728374, 62376588, 62522771, 62624943, 62742362, 62396348, 62530133, 62637095, 62749057, 62401156, 62534170, 62641120, 62757397, 62407514, 62538842, 62662172, 62766074, 62410673, 62542958, & 62668654.

Distribution pattern: Worldwide Distribution -- United States, including Puerto Rico; and, to the countries of Australia, Austria, Japan, Belgium, Italy, Switzerland, India, Germany, Spain, France, Israel, Netherlands, Saudi Arabia, South Africa & Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position.