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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Flexible Shaft

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  Class 2 Device Recall Synthes Flexible Shaft see related information
Date Initiated by Firm October 31, 2016
Date Posted November 23, 2016
Recall Status1 Terminated 3 on June 12, 2017
Recall Number Z-0656-2017
Recall Event ID 75580
Product Classification Reamer - Product Code HTO
Product Synthes Flexible Shaft, Orthopedic manual surgical instrument

The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
Code Information Part Number 352.040 - Lot # 9947895, L084498  Part Number 352.044 - Lot # 9916503 9916508,L000158,L000160,L000573,L000603,L000604,L000605,L000607,L000632 L082974 
Recalling Firm/
Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact
Manufacturer Reason
for Recall
Non-conforming material used.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm, DePuy Synthes, mailed an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 11/2016 to customers who were affected by the recall. The letter described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory to identify and quarantine all affected products; if you have product to return call DePuy Synthes at 1-800-479-6329 to obtain an RA; complete and return the Verification Section with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132 within 30 business days; send a copy of the completed Verification section via fax to 888-257-7905 or scan/email: Synthes3503@stericycle.com, even if you have no product to return; forward notice to anyone in your facility that needs to be informed; if any of the affected product has been forwarded to another facility, contact that facility to arrange return and keep a copy of the notice. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in Commerce 198 units
Distribution US Nationwide 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.