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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 8.5 MM Medullary Reamer

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  Class 2 Device Recall Synthes 8.5 MM Medullary Reamer see related information
Date Initiated by Firm October 03, 2013
Date Posted November 13, 2013
Recall Status1 Terminated 3 on August 26, 2016
Recall Number Z-0202-2014
Recall Event ID 66485
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Synthes 8.5 MM Medullary Reamer

Product Usage:
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
Code Information Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257 
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
FDA Determined
Cause 2		 Device Design
Action Synthes sent an Urgent Notice: Voluntary Medical Device Recall Notification letters, dated October 3, 2013, to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory and immediately remove the affected lots from stock. For questions call 610-719-5450 or contact your Synthes Sales Consultant.
Quantity in Commerce 2979
Distribution Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.
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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