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U.S. Department of Health and Human Services

Class 2 Device Recall Xcelerate Patella Reamer Shaft Assembly and Adapter

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  Class 2 Device Recall Xcelerate Patella Reamer Shaft Assembly and Adapter see related information
Date Initiated by Firm April 15, 2005
Date Posted August 27, 2008
Recall Status1 Terminated 3 on September 24, 2008
Recall Number Z-1778-2008
Recall Event ID 47829
Product Classification Reamer - Product Code HTO
Product Xcelerate Patella System Reamer Shaft Assembly;
Non-Sterile;
Howmedica Osteonics Corp.,
325 Corporate Drive;
Mahwah, NJ 07430
Authorized representative in Europe:
Stryker France ZAC Satolas Green Pusignan
Cedex, France
Code Information Product no. 8001-1702; Lot codes: MCYL30A, and MCYL30B.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Rita Intorella
201-831-5825
Manufacturer Reason
for Recall		 The Xcelerate Patella Reamer Shaft Assembly and the Reamer Adapter do not mate properly. This could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have enough bone for adequate engagement with pegs or patella fracture.
FDA Determined
Cause 2		 Process control
Action An IMPORTANT MARKET WITHDRAWAL letter was issued on April 19, 2005 and sent Federal Express to those consignees who received the device. The letter instructed them to examine their inventory to identify instruments, reconcile these instruments on an attached accountability form; fax a copy of this form within 2 days of receipt of the letter; retrieve and return affected product; contact Stryker Customer Service to re-order.
Quantity in Commerce 24 total
Distribution Class II Recall - Worldwide Distribution --- including USA and Canada, United Kingdom.
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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