Z-0475-2008

Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60

Name: Z-0475-2008 Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60
Creator: Stryker Howmedica Osteonics Corp.
Published: 2007-09-28
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-09-28 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60 on 2007-09-28. The reason FDA records is "Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of +12 should have been omitted". 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-0475-2008
Status: Terminated
Initiated: 2007-09-28
Posted: 2007-12-14
Terminated: 2008-09-05
Recalling firm: Howmedica Osteonics Corp
Product: Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of +12 should have been omitted.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Urgent Product Correction Letters, dated 10/17/2007 were sent on 10/17/07by Federal Express to all Stryker Branches/Agencies who had received the protocol. The branches were instructed to quarantine and destroy the protocols.
Quantity in commerce: 192 protocols
Distribution: Nationwide:The protocol was distributed to 9 Stryker branches/agencies in NJ, MD, IN, MI, MN, IL and TX.
Product codes and lots: Literature # LPS60 (Lot code n/a)

Product code LPH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)