| Class 2 Device Recall RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16 | |
Date Initiated by Firm | March 30, 2017 |
Create Date | May 02, 2017 |
Recall Status1 |
Terminated 3 on August 21, 2019 |
Recall Number | Z-1912-2017 |
Recall Event ID |
76943 |
Product Classification |
Chisel (osteotome) - Product Code KDG
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Product | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1) |
Code Information |
Batch numbers: 431604,431612,431614,448956,477931,484324,485498,488987,495483,450002910,4500029102, 4500031658,08CSY0044,08ESY0009,08ESY0010,08ESY0011,08JSY0034,08LSY0010,10CSY0008, 10ESY0014,11KSY0004,11KSY0024,12BSY0006,12BSY0014,12DSY0020,12HSY0009,12HSY0041, 12MSY0026,13BSY0032,13FSY0012,13FSY0023,13HSY0008,14BSY0015,14CSY0039,14GSY0025, 14KSY0003,15DSY0002,15FSY0020,15MSY0006,16BSY0010,477931B |
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 | 1004 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 |
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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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