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U.S. Department of Health and Human Services

Class 2 Device Recall Stem Extractor f/Guide Bar Epoca Revision Set

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 Class 2 Device Recall Stem Extractor f/Guide Bar Epoca Revision Setsee related information
Date Initiated by FirmMarch 19, 2018
Create DateApril 25, 2018
Recall Status1 Terminated 3 on April 11, 2019
Recall NumberZ-1514-2018
Recall Event ID 79698
Product Classification Extractor - Product Code HWB
ProductStem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
Code Information 09-6793, 10-2637, 10-5070, 12-2707, 14-1085, 15-8949
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact
610-719-5450
Manufacturer Reason
for Recall		There is a potential for the connection screw of the stem extractor to break.
FDA Determined
Cause 2		Device Design
ActionThe firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTICE" dated 3/19/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to the following: Review the instructions listed in this notification. Forward this 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. Keep a copy of this notice. Return the Verification Section (page 3 of this letter) to Synthes by: o Fax: 1-888-731-7954 or o Scan/email: Synthes3091@stericycle.com . Follow the Instructions if connecting screw for the stem extractor breaks If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in Commerce31
DistributionWorldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland.
Total Product Life CycleTPLC 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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