| Class 2 Device Recall Persona Distal Valgus Alignment Guide | |
Date Initiated by Firm | July 30, 2014 |
Date Posted | August 22, 2014 |
Recall Status1 |
Terminated 3 on March 06, 2015 |
Recall Number | Z-2543-2014 |
Recall Event ID |
68801 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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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. |
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. |
Recalling Firm/ Manufacturer |
Zimmer, Inc. 1800 W Center St Warsaw IN 46580-2304
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For Additional Information Contact | 800-447-5633 |
Manufacturer Reason for Recall | Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position. |
FDA Determined Cause 2 | Device Design |
Action | An Urgent Medical Device Correction letter dated, July 31, 2014, was issued to consignees. The letter identified the affected product, the problem, the risks, and responsibilities. Risk managers and surgeons are to review the notification and the updated surgical technique provided in Attachment 1; as well as, ensure that all affected personnel are aware of the contents. Questions or concerns should be directed to Zimmer customer call center at 1-877-946-2761. |
Quantity in Commerce | 2,248 units |
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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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