—#49480

Product

Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.

FDA product code: MBB — Bone Cement, Antibiotic
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K014199
Affected lot / code info: 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

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2006-11-07
Posted by FDA: 2007-01-10
Terminated: 2007-02-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49480. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.