FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.
- Recall number
- Z-0467-2007
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.
- Status
- Terminated
- Initiated
- 2006-11-07
- Posted
- 2007-01-10
- Terminated
- 2007-02-28
- Reason
- 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
- 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
- 813 units
- Distribution
- Nationwide
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K014199"]
- PMA numbers
- not on file
- Product code
- MBB
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28