Z-2543-2014 Class II Terminated
FDA device recall Z-2543-2014 was initiated by Zimmer, Inc. on Jul 30, 2014 and is designated Class II. Reason for recall: Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position. The recall status is terminated (terminated Mar 6, 2015). Affected quantity: 2,248 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 3, 2014
- Initiation Date
- Jul 30, 2014
- Termination Date
- Mar 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,248 units
Product Description
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.
Reason for Recall
Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position.
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.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2543-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026