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.
Check against the official notice below — it lists the full affected range.
Zimmer, Inc. is recalling 2,248 units of the Zimmer PERSONA Distal Valgus Alignment Guide, a nonsterile orthopedic surgical instrument used to set proper knee alignment during surgery. The device is affected by a defect in which the collet locks seize in the unlocked position. The recalled units were distributed worldwide to the United States (including Puerto Rico), Australia, Austria, Japan, Belgium, Italy, Switzerland, India, Germany, Spain, France, Israel, Netherlands, Saudi Arabia, South Africa, and Canada.
The affected devices have Item Number 42509900400 and one of 40 specific lot numbers listed in the recall notice. The source does not specify a remedy or corrective action for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position.
Reason for recall: Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position. Distribution: 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. Quantity: 2,248 units Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.