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Terminated

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.

FDA Recall Z-2543-2014 · Posted 2014-08-22

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2014-07-30
Date Terminated2015-03-06
Product Quantity2,248 units

Reason for Recall

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

Firm 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.

Root Cause

Device Design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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