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U.S. Department of Health and Human Services

Class 2 Device Recall RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14

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  Class 2 Device Recall RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14 see related information
Date Initiated by Firm March 30, 2017
Create Date May 02, 2017
Recall Status1 Terminated 3 on August 21, 2019
Recall Number Z-1911-2017
Recall Event ID 76943
Product Classification Chisel (osteotome) - Product Code KDG
Product RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
Code Information Batch numbers:  431604,431612,431614,448956,469005,472361,472767,483297,483890,488786,496187,4500029102, 07LSY0037,07LSY0042,08ESY0005,08ESY0005A,08ESY0007,08ESY0008,08JSY0009,08JSY0009A, 08LSY0050,09BSY0019,09FSY0003,10CSY0007,10ESY0013,11GSY0006,11HSY0009,11KSY0003, 11KSY0069,11MSY0021,12FSY0002,12FSY0029,12GSY0007,12HSY0025,12HSY0040,12KSY0024, 12LSY0021,12MSY0005,12MSY0013,12MSY0025,13BSY0009,13BSY0016,13FSY0022,13JSY0022, 13KSY0048,13MSY0006,14CSY0006,14CSY0038,14HSY0006,15ASY0009,15ASY0018,15ASY0022, 15FSY0016,15JSY0006,15KSY0023,15KSY0039,15MSY0005,16ESY0059,16ESY0075,488369A  
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David Snyder
978-749-1440
Manufacturer Reason
for Recall		 The stability data does not support the product labeled with a 10-year shelf life.
FDA Determined
Cause 2		 Error in labeling
Action The firm initiated their recall by email and letter on 03/30/2017. Consignees were asked to inspect inventory to locate and quarantine affected product. All consignees are asked to complete a Response Form provided with the Field Safety Notice, regardless whether they have affected product. Affected inventory is then to be returned back to Smith & Nephew.
Quantity in Commerce 1126 units
Distribution Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela
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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