Z-0783-2014Class II

Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting...

Name: Z-0783-2014 Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting...
Creator: Zimmer, Inc.
Published: 2013-12-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-12-19 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously... on 2013-12-19. FDA classified it as Class II and gives the reason as "After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient...". 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-0783-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-19
Posted: 2014-01-17
Terminated: 2015-02-24
Recalling firm: Zimmer GmbH
Product: Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.
Root cause tag: design
FDA root cause: Device Design
Action: Depth of recall " Notifications were sent to customers, surgeons and risk managers, which use the affected product. Distributors were also informed of the notifications sent to surgeons and risk managers. The customers were identified by performing an invoice search and distribution history for the Polyethylene Inserts (00-5850-012-95 and 00-5850-013-95) since product launch. Recall Communication " All distributors were notified via electronic mail. Distributors that have received affected inventory were also notified via courier. Hospital risk managers and surgeons were also notified via courier. On 12/19/13, hospital risk managers and surgeons were provided with a notification identifying the issue and their responsibilities. These responsibilities include ensuring the affected personnel are aware of the contents of the notification. On 12/19/13, Distributors were sent a notification identifying the issue and to provide a copy of the notification sent to surgeons and risk managers. The distributors will also be instructed as needed to assist with identifying a comprehensive list of surgeons. " Communications outside of the United States will occur approximately two weeks after the United States communications. Effectiveness Checks Zimmer will conduct effectiveness checks in the following way: "Surgeons/Hospitals o100% of the FedEx notifications will be accounted for. oSecond and third notification attempts will be made. oFailed delivery attempts following the third attempt will result in the account being deemed as nonresponsive.
Quantity in commerce: 5305 distribution events
Distribution: Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.
Product codes and lots: Part numbers 00-5850-012-95

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0783-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0783-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-17
Z-0784-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-17

Product code KRO

K070978Class IIZimmer Segmental SystemZimmer, Inc. / cleared 2007-07-03

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