Z-0193-2012

Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah...

Name: Z-0193-2012 Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2011-06-03
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2011-06-03 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan... on 2011-06-03. The reason FDA records is "Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0193-2012
Status: Terminated
Initiated: 2011-06-03
Posted: 2011-11-16
Terminated: 2013-11-13
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France The Restoration ADM System X# Acetabular Insert is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 28mm diameter femoral heads.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: The firm, Stryker, sent an "URGENT PRODUCT CORRECTION" letter and Product Correction Bulletin dated June 3, 2011 via Fed Ex to its customers. The letter and bulletin describes the issue, potential hazards, risk mitigation and product correction instructions. The customers were instructed to complete and return the enclosed PRODUCT CORRECTION ACKNOWLEDGMENT FORM within 5 days via fax to: 201-831-6069. If you have any questions, feel free to call (201) 972-2100 or Hip Marketing Team at 201-831-5280.
Quantity in commerce: 1677 units
Distribution: Nationwide distribution.
Product codes and lots: Catalog No.: 1236-2-8XX (XX=46, 48, 50, 52, 54, 56, 58, 60, 62, 64) All Lots K093644

Product code LZO

K093644Class IIRestoration Adm System X3 AcetabularHowmedica Osteonics Corp. / cleared 2009-12-18

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)