Stryker Howmedica Osteonics Corp. Simplex P with Tobramycin. Antibiotic PMMA Bone Cement. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
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
Products Sold
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
Stryker Howmedica Osteonics Corp. is recalling Simplex P with Tobramycin. Antibiotic PMMA Bone Cement. due to The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External la. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026