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Terminated

Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.

FDA Recall Z-0467-2007 · Posted 2007-01-10

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMBB
Date Initiated2006-11-07
Date Terminated2007-02-28
Product Quantity813 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K014199SURGICAL SIMPLEX P WITH TOBRAMYCINHowmedica Osteonics Corp. · 2003-05-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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