Z-0071-2011

Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control, 00-8790-003-00, Zimmer Inc...

Name: Z-0071-2011 Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control, 00-8790-003-00, Zimmer Inc...
Creator: Zimmer Inc.
Published: 2010-03-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-03-19 / Terminated / root cause: design

FDA source

Zimmer Inc. began a recall of Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control, 00-8790-003-00, Zimmer Inc., Warsaw, IN. Used to mate the inserter with the shell... on 2010-03-19. The reason FDA records is "The firm has received reports of users encountering difficulties in usage leading to surgical delays or minor damage to a threaded surface of the shell implant". 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-0071-2011
Status: Terminated
Initiated: 2010-03-19
Posted: 2010-10-15
Terminated: 2011-01-12
Recalling firm: Zimmer GmbH
Product: Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control, 00-8790-003-00, Zimmer Inc., Warsaw, IN. Used to mate the inserter with the shell implant.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The firm has received reports of users encountering difficulties in usage leading to surgical delays or minor damage to a threaded surface of the shell implant.
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent Urgent: Device Removal letters dated 3/15/2010. The letter identified the affected product, described the issue, discussed the clinical implications, and provided a list of required actions. The consignees were instructed to perform an inventory of the recalled product and report the amount on hand to Zimmer by completing the Inventory Return Certification Form. After Zimmer received the report, they would send out new product to the consignee. After new product was received the consignees were instructed to return the recalled product to Zimmer. The firm expects to have all product replaced by 4/30/2010. If there are any questions or additional info needed, consignees should contact Zimmer, Inc. at 1-800-613-6131 or 574-372-4463.
Quantity in commerce: 1125 all products
Distribution: Worldwide Distribution -- US, Singapore, Australia, Portugal, Germany, Switzerland, Spain, Finland, United Kingdom, Israel, Italy and Sweden.
Product codes and lots: 61301130, 61309997, 61326687, 61330544, 61389660, 61407677 and 61426853.

Product code LXH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)