Z-0467-2007

Simplex P with Tobramycin. Antibiotic PMMA Bone Cement

Name: Z-0467-2007 Simplex P with Tobramycin. Antibiotic PMMA Bone Cement
Creator: Stryker Howmedica Osteonics Corp.
Published: 2006-11-07
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2006-11-07 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Simplex P with Tobramycin. Antibiotic PMMA Bone Cement on 2006-11-07. The reason FDA records is "The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration date than the actual...". 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-0467-2007
Status: Terminated
Initiated: 2006-11-07
Posted: 2007-01-10
Terminated: 2007-02-28
Recalling firm: Howmedica Osteonics Corp
Product: Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.
Product code: MBB Bone Cement, Antibiotic
Reason for recall: The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration date than the actual subcomponents will support.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A recall notification was sent by Federal Express on 11/7/06. The firm will follow-up with telephone calls and follow-up letters as necessary.
Quantity in commerce: 813 units
Distribution: Nationwide
Product codes and lots: Lot Code MBN003, catalog no. 6197-9-010 (10 pk) Lot Code MBN003, catalog no. 6197-9-001 (1 pk) Lot Code MBN004; catalog no. 6197-9-010 (10 pk) Lot code MBN004; catalog no. 6197-9-001 (1 pk) Lot Code MBN003 and MBN004 - powder ''use by'' date 12/2007 Lot Code MBN003 and MBN004 - liquid ''use by'' date 9/2006 Product ''Use By'' Date: September 2006

Product code MBB

K014199Class IISurgical Simplex P with TobramycinHowmedica Osteonics Corp. / cleared 2003-05-06

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)