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U.S. Department of Health and Human Services

Class 2 Device Recall Simplex P

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 Class 2 Recall
Simplex P
see related information
Date Posted January 10, 2007
Recall Status1 Terminated on February 28, 2007
Recall Number Z-0467-2007
Recall Event ID 36871
Premarket Notification
510(K) Number
K014199 
Product Classification Bone Cement, Antibiotic - Product Code MBB
Product Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.
Code Information 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
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Rita Intorrella
201-831-5825
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Labeling Design
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 in Commerce 813 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MBB and Original Applicant = HOWMEDICA OSTEONICS CORP.
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