Z-2543-2014Class II

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

Name: Z-2543-2014 Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the...
Creator: Zimmer, Inc.
Published: 2014-07-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-07-30 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee... on 2014-07-30. FDA classified it as Class II and gives the reason as "Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2543-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-30
Posted: 2014-08-22
Terminated: 2015-03-06
Recalling firm: Zimmer GmbH
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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2543-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2543-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-22

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)