Z-1102-2010

Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem; Titanium, Alloy and...

Name: Z-1102-2010 Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem; Titanium, Alloy and...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-12-30
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-12-30 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem; Titanium, Alloy and Hydroxyapatite. Catalog number: 6276-5-014 on 2009-12-30. The reason FDA records is "The Restoration Modular Hip Stem may have two different package labels. The 14 mm diameter stem may be labeled with both a size 14 mm diameter and a 26 mm diameter". 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-1102-2010
Status: Terminated
Initiated: 2009-12-30
Posted: 2010-03-11
Terminated: 2012-09-14
Recalling firm: Howmedica Osteonics Corp
Product: Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem; Titanium, Alloy and Hydroxyapatite. Catalog number: 6276-5-014.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: The Restoration Modular Hip Stem may have two different package labels. The 14 mm diameter stem may be labeled with both a size 14 mm diameter and a 26 mm diameter.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker Branches were notified by e-mail on December 30, 2009. This was followed by a formal recall letter by Fed Ex sent on 1/11/10 to branches as well as the hospital and surgeon that used the device.
Quantity in commerce: 1
Distribution: 1 device distributed to a hospital in GA.
Product codes and lots: Catalog number: 6276-5-014; Lot number: 20568201, Exp 11/23/2011.

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)