Z-0587-2014Class II

Dist Lat Fem Lock Plt, Lt

Name: Z-0587-2014 Dist Lat Fem Lock Plt, Lt
Creator: Zimmer, Inc.
Published: 2013-11-05
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-11-05 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of DIST LAT FEM LOCK PLT, LT on 2013-11-05. FDA classified it as Class II and gives the reason as "Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the...". 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-0587-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-05
Posted: 2013-12-27
Terminated: 2015-05-05
Recalling firm: Zimmer GmbH
Product: Dist Lat Fem Lock Plt, Lt
Product code: FZS Curette, Surgical, General Use
Reason for recall: Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure
Root cause tag: packaging
FDA root cause: Process change control
Action: On 11/5/2013, Urgent Medical Device Recall Notifications were sent to affected distributors, hospital Risk Managers, and doctors informing them of the failure. All distributors were notified via electronic mail. Hospital risk managers, surgeons and distributors with affected inventory within the expiration date of the device will also be notified via courier. The letter identifies the issue, health risks, and their responsibilities. Questions concerning the recall are directed to 1-877-946-2761 Communications outside of the United States will occur approximately two weeks after the United States communications. Zimmer will conduct effectiveness checks in the following way: Distributors/Hospitals/Surgeons 100% of the notifications will be tracked to ensure delivery of the notifications. An inventory certification form will need to be returned from each distributor that certifies that all available affected product from their territory has been returned. Additional notifications via email and FedEx will be sent to those who have not completed the required certification form or returned affected product. Accounts will be deemed unresponsive after 3 attempts.
Quantity in commerce: 42, 065 units total
Distribution: Worldwide Distribution.
Product codes and lots: Item Number: 47-2357-102-14 47-2357-102-18 All lots with an expiration date prior to July 24, 2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0587-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0585-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27
Z-0586-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27
Z-0587-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27
Z-0588-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27
Z-0589-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27
Z-0590-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27
Z-0591-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27
Z-0592-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27

Product code FZS

K082078Class IIZimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna PlatesZimmer, Inc. / cleared 2008-11-03

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)