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U.S. Department of Health and Human Services

Class 2 Device Recall SUTUREFIX ULTRA Suture

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  Class 2 Device Recall SUTUREFIX ULTRA Suture see related information
Date Initiated by Firm June 24, 2020
Create Date July 31, 2020
Recall Status1 Open3, Classified
Recall Number Z-2746-2020
Recall Event ID 85981
510(K)Number K122059  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product SUTUREFIX ULTRA Suture, Product number 72203855
Code Information Lot numbers 2038366, 2039311 and 2046505
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
150 Minuteman Rd
Andover MA 01810-1031
Manufacturer Reason
for Recall		 A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.
FDA Determined
Cause 2		 Process control
Action On June 24, 2020, the firm distributed Urgent Medical Device Recall Notices to their customers. Customers were informed that due to a packaging error, packages labeled as a 1.7mm twist drill (S) instead contained a 1.7mm (XL) drill. The overall length of the XL drill (12 inches) is longer than the S drill (11 inches). Customers were asked to do the following: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with the Urgent Medical Device Recall Notice, and quarantine them immediately. 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. 2. If you have no product to return, please indicate this on the response form included with the letter. 3. If you have product to return, please list the item, batches and quantities that you are returning on the customer response form. 4. Complete the remainder of the customer response form, sign and send to FieldActions@smith-nephew.com. 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 868
Distribution Domestic distribution to AL AR AZ CO GA IL IN KS KY MD MN MO NC NE NJ NY OK PA PR TN TX VA WI. Foreign distribution to Australia Austria Belgium Finland France Germany Great Britain Ireland Italy Japan Luxembourg Mexico Netherlands Poland Portugal Singapore South Africa Spain Sweden Switzerland
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.
510(K) Database 510(K)s with Product Code = MBI and Original Applicant = SMITH & NEPHEW, INC.
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