Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Var

FDA device recall Z-2543-2014 · posted 2014-08-22 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

LXH

Quantity affected

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, Sau

Date initiated

2014-07-30

Date posted

2014-08-22

Date terminated

2015-03-06

Location

Warsaw, IN