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U.S. Department of Health and Human Services

Class 2 Device Recall 8.5mm Reamer Head for Flexible Intramedullary Nailing System

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  Class 2 Device Recall 8.5mm Reamer Head for Flexible Intramedullary Nailing System see related information
Date Initiated by Firm July 01, 2015
Date Posted August 10, 2015
Recall Status1 Terminated 3 on August 26, 2016
Recall Number Z-2359-2015
Recall Event ID 71729
Product Classification Reamer - Product Code HTO
Product 8.5mm Reamer Head for Flexible Intramedullary Nailing System; 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, burr, 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 Number 352.085, Sold lot numbers: 4399543 4411503 4420609 4425217 4500163 4500164 4500686 4516589 4606034 4606035 4619636 4631667 4646360 4658303 4660046 4676339 4691146 4691147 4705949 4720351 4720352 4757916 4769298 4769248 4799766 4790646 4798484 4856180 4882851 4899798 4919634 4937255 4937251 4956701 4956699 4977566 4994239 5018161 5018284 5034158 5034157 5050564 5052365 5065433 5087496 5102055 5102054 5124415 5124416 5140714 5140716 5161068 5185228 5203705 5226958 5226959 5248981 5249272 5249274 5249278 5294388 5299855 5299857 5299856 5299858 5362321 5454350 5454351 5471078 5493666 5508984 5535700 5554801 5575607 5582834 5610290 5635000 5652084 5665722 5697107 5718304 5735831 5756081 5769433 5784706 5813830 5837326 5870257 20141 20290 20291 21025 20713 21372 21677 21829 22717 20292 22981 21201 22592 23390 21927 23439 23944 24091 24334 24510 24917 24934 25076 25171 25178 4800264 4803085   
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact Customer Support
610-719-6500
Manufacturer Reason
for Recall		 The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot numbers identified. No new adverse events reported.
FDA Determined
Cause 2		 Other
Action An urgent notice of medical device recall, dated July 1, 2015, was sent to end users and sales consultants to alert them about the device defect and potential risk to patients. Recipients were asked to complete the verification form and return it along with any affected devices their posession.
Quantity in Commerce 4329
Distribution Worldwide Distribution.
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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