Z-0507-2010

OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325 Corporate Drive...

Name: Z-0507-2010 OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325 Corporate Drive...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-08-31
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-08-31 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325 Corporate Drive, Mahwah, NJ 07430. Surgical protocols instruct surgeons... on 2009-08-31. The reason FDA records is "Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone". 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-0507-2010
Status: Terminated
Initiated: 2009-08-31
Posted: 2010-01-11
Terminated: 2013-07-17
Recalling firm: Howmedica Osteonics Corp
Product: OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325 Corporate Drive, Mahwah, NJ 07430. Surgical protocols instruct surgeons on proper surgical technique.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: "Urgent Product Correction - Surgical Protocol" letters and Product Accountability Forms were sent to consignees via Fed Ex on August 31, 2009 and September 1, 2009 with return receipt. Notification letters described the issue, protocols affected, potential hazard and harm and risk mitigation. Direct questions about the recall by calling 1-201-972-2100 or Customer Service 1 -866-OR-ASSIST (1 -866-672-7747).
Quantity in commerce: 2,876
Distribution: Worldwide Distribution.
Product codes and lots: Catalog Number/Lot Code: LSP46.

Product code LZO

K022555Class IIAccolade C Femoral StemsHowmedica Osteonics Corp. / cleared 2002-08-26

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)