Z-2178-2009

Restoration Modular Calcar Body, 21 mm +20 mm; Stryker Orthopaedics. Intended to be used for primary or...

Name: Z-2178-2009 Restoration Modular Calcar Body, 21 mm +20 mm; Stryker Orthopaedics. Intended to be used for primary or...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-06-26
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-06-26 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Restoration Modular Calcar Body, 21 mm +20 mm; Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the... on 2009-06-26. The reason FDA records is "The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls...". 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-2178-2009
Status: Terminated
Initiated: 2009-06-26
Posted: 2009-09-14
Terminated: 2010-07-27
Recalling firm: Howmedica Osteonics Corp
Product: Restoration Modular Calcar Body, 21 mm +20 mm; Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by this vendor has raised concern about their supplied raw material. As a precaution and due to the potential impact on the mechanical properties of the products, St
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.
Quantity in commerce: 203 - all varieties
Distribution: Worldwide Distribution
Product codes and lots: Catalog number: 6276-4-221; REST MOD CALCAR BODY 21mm +20mm T80551AA 28-Jan-2014 REST MOD CALCAR BODY 21mm +20mm T80551AA 28-Jan-2014 REST MOD CALCAR BODY 21mm +20mm T80551AA 28-Jan-2014 REST MOD CALCAR BODY 21mm +20mm T80551AA 28-Jan-2014

Product code LZO

K013106Class II2 Piece Modular Hip StemHowmedica Osteonics Corp. / cleared 2002-04-03

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)