Simplex P with Tobramycin. Antibiotic PMMA Bone Cement recallZ-0467-2007 · Stryker Howmedica Osteonics Corp. · initiated Nov 7, 2006
Terminated All recalls posted in January 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0467-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 7, 2006
- Posted by the FDA
- Jan 10, 2007
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 813 units
- Product code
- MBB
- FDA submissions
- K014199
- Distribution
- Nationwide
Product description
Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.
Code information (models, lots, serial 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; 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
Other devices under the same FDA submission
1 device cleared under K014199 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Simplex 6197-9-001Howmedica Osteonics Corp. · BONE CEMENT2 deaths57 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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