Z-2546-2014Class II

Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS...

Name: Z-2546-2014 Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS...
Creator: Zimmer, Inc.
Published: 2014-07-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-07-22 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM on 2014-07-22. FDA classified it as Class II and gives the reason as "Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2546-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-22
Posted: 2014-08-26
Terminated: 2015-09-15
Recalling firm: Zimmer GmbH
Product: Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.
Quantity in commerce: 972,125 units
Distribution: Worldwide Distribution.
Product codes and lots: Item Numbers 00579104100, 00579104200, 00598304048, 00598304148 Exp Date Prior to 2023-11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2546-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2546-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2547-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2548-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2549-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2550-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2551-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2552-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26

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)