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U.S. Department of Health and Human Services

Class 2 Device Recall RIKKI Retractor

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  Class 2 Device Recall RIKKI Retractor see related information
Date Initiated by Firm August 03, 2020
Create Date August 17, 2020
Recall Status1 Open3, Classified
Recall Number Z-2818-2020
Recall Event ID 86187
Product Classification Retractor - Product Code GAD
Product Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
Code Information Lot Numbers: 18DM14901, 18FM21215, 18DM07309, 18GM20885, 19EM21519, 18JM05681, 19EM21520
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
Manufacturer Reason
for Recall		 The products were improperly heat treated.
FDA Determined
Cause 2		 Process control
Action Smith and Nephew issued an Urgent Medical device recall notice. It states the following: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers in this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table below. 2. If you have no product to return, please put an X in the appropriate location. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes. 4. Complete the remainder of the form, sign and send to FieldActions@smith-nephew.com. Please Note  even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.
Quantity in Commerce 111 units
Distribution US states: CA CO CT GA HI IL IN KY MA MD NC NY OK PA SD TN WA WI OUS countries: AE CO JP KR PL ZA
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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