SUTUREFIX ULTRA Suture, Product number 72203855
Recall
- Recall Number
- Z-2746-2020
- Event Number
- 85981
- Firm
- Smith & Nephew, Inc.
- FEI Number
- 3003604053
- Product Code
- MBI
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- June 24, 2020
- Address
- 150 Minuteman Rd, Andover, MA, 01810-1031
Description
SUTUREFIX ULTRA Suture, Product number 72203855
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.
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 [email protected]. 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 [email protected].
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
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