| Class 2 Device Recall SUTUREFIX ULTRA Suture | |
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
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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
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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 |
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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 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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510(K) Database | 510(K)s with Product Code = MBI
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