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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Flexible Medullary Reamer

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 Class 2 Recall
Synthes Flexible Medullary Reamer
see related information
Date Posted August 12, 2013
Recall Status1 Open
Recall Number Z-1952-2013
Recall Event ID 65560
Product Classification Reamer - Product Code HTO
Product Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
Code Information All lots with part number 359.106, 359.107, 359.108, 359.109, 359.110, 359.111, 359.112, 359.113, 359.114, 359.115
Recalling Firm/
Manufacturer
Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Synthes Recall Information
610-719-5450
Manufacturer Reason
for Recall
Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.
FDA Determined
Cause 2
DESIGN: Device Design
Action Sythes notified direct accounts by letter on 6/11/13 and requested them to check their inventory and remove affected lots from stock. Synthes requested that affected lots be returned and to call Synthes at 1-800-479-6329 for a Return Authorization Number. Completion and return of the Verification section at the end of the letter was requested, including negative responses.
Quantity in Commerce 13,050
Distribution Nationwide Distribution.
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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