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U.S. Department of Health and Human Services

Class 2 Device Recall Radial Osteotome Blade

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 Class 2 Device Recall Radial Osteotome Bladesee related information
Date Initiated by FirmOctober 23, 2017
Create DateJanuary 24, 2018
Recall Status1 Terminated 3 on August 24, 2018
Recall NumberZ-0406-2018
Recall Event ID 78429
Product Classification Instrument, manual, surgical, general use - Product Code MDM
ProductRadial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
Code Information Lot Numbers: 14HSY0006R, 15MSY0005R, 15KSY0023R, 09FSY0003R, and 12HSY0040R.
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact
901-396-2121
Manufacturer Reason
for Recall		The expiration date provided on the label is incorrect.
FDA Determined
Cause 2		Process change control
ActionThe firm initiated their recall by an Urgent Medical Device Recall Notice on 10/23/2017. The letter identified the affected device and the reason for the recall, as well as the potential risk. The firm instructed users to please inspect their inventory and locate any unused devices from the list of product and batch numbers provided in the Notice. Affected devices must be quarantined immediately. Distributors, must notify their customers of the field action and ensure that the actions are carried out. The attached form should be completed and returned. Questions or concerns can be directed to FieldActions@smith-nephew.com.
Quantity in Commerce9 units
DistributionWorldwide Distribution -- US, to the states of TN and NJ; and, Australia.
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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