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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes

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 Class 2 Recall
Synthes
see related information
Date Posted June 16, 2010
Recall Status1 Open
Recall Number Z-1804-2010
Recall Event ID 55438
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Synthes Medullary Tubes
Code Information Catalog number 355.01. all lot numbers
Recalling Firm/
Manufacturer
Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
For Additional Information Contact Lynne Lewis
800-620-7025
Manufacturer Reason
for Recall
After repeated sterilizations product may become discolored and break including while in the medullary canal. Synthes has determined that the Medullary Tube will be a single use item that is to be discarded after one sterilization cycle.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The recalling firm issued an Urgent medical Device Recall letter dated 4/9/10 to all trauma hospital accounts informing them of the problem and the need to return the products. All sales consultants were notified via email and letter. Questions are directed to the company at 800-620-7025 x 5452 or 610-719-5452, or contact your Synthes Trauma Sales Consultant.
Quantity in Commerce 18,505 tubes
Distribution The product was shipped to medical facilities 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.
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