Z-0884-2009

Restoration Modular Conical Distal Stem; Sterile, Titanium Alloy. One unit per package. Stryker Ireland...

Name: Z-0884-2009 Restoration Modular Conical Distal Stem; Sterile, Titanium Alloy. One unit per package. Stryker Ireland...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2008-11-21
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-11-21 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Restoration Modular Conical Distal Stem; Sterile, Titanium Alloy. One unit per package. Stryker Ireland Carrigtwohill County Cork, Ireland. Authorized... on 2008-11-21. The reason FDA records is "Stryker became aware of a lot for lot mix up". 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-0884-2009
Status: Terminated
Initiated: 2008-11-21
Posted: 2009-01-26
Terminated: 2012-06-25
Recalling firm: Howmedica Osteonics Corp
Product: Restoration Modular Conical Distal Stem; Sterile, Titanium Alloy. One unit per package. Stryker Ireland Carrigtwohill County Cork, Ireland. Authorized Representative in Europe: Stryker France, Cedex France. This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of servere proximal bone loss.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Stryker became aware of a lot for lot mix up.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Recall notification letters sent via Federal Express on Nov. 21, 2008 to Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons. Letters explain the labeling mix up and the potential risks to patients if the wrong size stem is used. Stryker branches are asked to examine inventory and that of hospital locations to identify affected product. All affected product is to be reconciled on the Product Accountability form and the form faxed back to Stryker. Contact Stryker Howmedical Osteonics Corporation for additional information at 1-201-831-5718.
Quantity in commerce: 4
Distribution: Class II Recall - Nationwide Distribution
Product codes and lots: Catalog No. 6276-7-017 (17mm), Lot Code CAXHA68D; Catalog No. 6276-7-014, (14mm) Lot Code CAXHB18A

Product code LZO

K022549Class IIRestoration Modular SystemHowmedica Osteonics Corp. / cleared 2002-09-23

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)