—#128765

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected 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.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

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.

Timeline

Recall initiated: 2014-07-30
Posted by FDA: 2014-08-22
Terminated: 2015-03-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128765. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.