Z-0094-2015Class II

Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip...

Name: Z-0094-2015 Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip...
Creator: Zimmer, Inc.
Published: 2014-10-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-10-01 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer on 2014-10-01. FDA classified it as Class II and gives the reason as "The affected products are missing polar boss threads". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0094-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-01
Posted: 2014-10-20
Terminated: 2015-03-02
Recalling firm: Zimmer GmbH
Product: Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: The affected products are missing polar boss threads.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Zimmer sent an "URGENT MEDICAL DEVICE RECALL- LOT SPECIFIC" notifications dated October 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your Responsibilities 1. Review the notification and ensure affected personnel are aware of the contents. 2. If you find any product from the affected lot , quarantine the product and notify your Zimmer sales representative. 3. Your Zimmer sales representative will remove the recalled product from your facility. 4. For patients that previously had this product implanted, it is recommended that you continue your normal post operative follow up routine. 5. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 5:00pm EST.
Quantity in commerce: 19
Distribution: Worldwide Distribution: US (nationwide) in the states of : IA, CA, NC, AL, WA, FL, TN, MA, AZ, TX, UT, and NV; and Internationally to Japan.
Product codes and lots: Part Number: 00-8757-068-02; Lot Number: 62207029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0094-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0094-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-20

Product code JDI

K091508Class IIZimmer Continuum Acetabular System, Zimmer Trilogy It Acetabular SystemZimmer, Inc. / cleared 2009-09-11

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)