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U.S. Department of Health and Human Services

Class 2 Device Recall Howmedica Osteonics

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  Class 2 Device Recall Howmedica Osteonics see related information
Date Initiated by Firm July 17, 2003
Date Posted August 21, 2003
Recall Status1 Terminated 3 on September 03, 2003
Recall Number Z-1143-03
Recall Event ID 26863
Product Classification Instrument, Cutting, Orthopedic - Product Code HTZ
Product Femoral Resection Guide, Scorpio L.R.S. Instrumentation.
Code Information Catalog No: 8050-5103; 8050-5105; 8050-5107; 8050-5109; 8050-5111; 8050-5113. 
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics
300 Commerce Court
Mahwah NJ 07430
For Additional Information Contact Dominick Cristofolo
201-831-5247
Manufacturer Reason
for Recall		 Scorpio Femoral Resection Guides have the potential to remove more bone than necessary.
FDA Determined
Cause 2		 Other
Action Product recall letters and product accountability forms were sent via FedEx to all Branches/sales agents on July 17, 2003. For the Canadian and International customers, the recall notification was also sent on July 17, 2003. All devices are to be returned to Howmedica Osteonics, Mahwah, NJ.
Quantity in Commerce 102
Distribution The catalog numbers were sent to Howmedica Osteonics Sales Representatives/agents, one Canada Howmedica Sales Representative, and one International Howmedica location in Ireland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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