Z-1201-2010

Howmedica Restoration ADM Trial Cup Holder; Non Sterile; Benoist Girard, Cedex, France; Distributed by...

Name: Z-1201-2010 Howmedica Restoration ADM Trial Cup Holder; Non Sterile; Benoist Girard, Cedex, France; Distributed by...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2010-01-21
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2010-01-21 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Howmedica Restoration ADM Trial Cup Holder; Non Sterile; Benoist Girard, Cedex, France; Distributed by Howmedica Osteonics Corp. Mahwah, NJ. The intended use... on 2010-01-21. The reason FDA records is "The Restoration ADM Trial Cup Holder may not have been assembled correctly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1201-2010
Status: Terminated
Initiated: 2010-01-21
Posted: 2010-04-19
Terminated: 2012-06-20
Recalling firm: Howmedica Osteonics Corp
Product: Howmedica Restoration ADM Trial Cup Holder; Non Sterile; Benoist Girard, Cedex, France; Distributed by Howmedica Osteonics Corp. Mahwah, NJ. The intended use: The Restoration ADM Window Trial is locked onto the Restoration ADM Trial Cup Holder and placed into the acetabulum to evaluate the size and congruity of the preparation for visualization and assessment of fit, contact and congruency of the trial within the acetabulum.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: The Restoration ADM Trial Cup Holder may not have been assembled correctly.
FDA root cause: Other
Action: An "URGENT PRODUCTION OPERATION" letter dated January 21, 2010, was sent to customers via FedEx. The letter described the product, problem and actions to be taken by customer. The customers should follow the instructions on the enclosed PRODUCT BULLETIN. The customer should check their internal inventory immediately and quarantine all affected devices, identify if the device is correctly assembled and complete the Product Correction Acknowledgement Form and fax it to (201) 831-6069. If you have any questions, feel free to contact Rich Wolyn, Manager, Divisional Regulatory Reporting at (201) 831-5158.
Quantity in commerce: 5 units
Distribution: Nationwide distribution: AZ, CA and OR
Product codes and lots: Catalog number: 1235-0-000; Lot number: G2546019

Product code MEH

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)