Z-0619-2011

Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF 9363-32-057, Zimmer, Warsaw...

Name: Z-0619-2011 Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF 9363-32-057, Zimmer, Warsaw...
Creator: Zimmer Inc.
Published: 2010-11-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-11-15 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF 9363-32-057, Zimmer, Warsaw, IN on 2010-11-15. The reason FDA records is "Mislabeled - Device packages labeled as hooded trial inserts contain standard trial inserts". 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-0619-2011
Status: Terminated
Initiated: 2010-11-15
Posted: 2010-12-14
Terminated: 2011-05-23
Recalling firm: Zimmer GmbH
Product: Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF 9363-32-057, Zimmer, Warsaw, IN.
Product code: HWT Template
Reason for recall: Mislabeled - Device packages labeled as hooded trial inserts contain standard trial inserts.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Zimmer contacted the two affected accounts directly by phone on November 15, 2010 to inform them of the recall. Zimmer will monitor the return of the affected instruments and account for the outstanding instruments until the removal action is complete. Each of the affected accounts will be provided with a new trial insert, manufactured and packaged with the correct component. The accounts will be asked to return the affected units back to Zimmer where the returned product will be destroyed. Customers can contact Zimmer at 574 371-8852 concerning this recall.
Quantity in commerce: 3
Distribution: Worldwide Distribution: US in the states of KS and UT, and the country of Canada.
Product codes and lots: 61438482

Product code HWT

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