FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: SUTUREFIX ULTRA Suture, Product number 72203855
- Recall number
- Z-2746-2020
- Recalling firm
- Smith & Nephew, Inc.
- Product
- SUTUREFIX ULTRA Suture, Product number 72203855
- Status
- Open, Classified
- Initiated
- 2020-06-24
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- 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
- 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
- Lot, serial or model codes
- Lot numbers 2038366, 2039311 and 2046505
- 510(k) numbers
- ["K122059"]
- PMA numbers
- not on file
- Product code
- MBI
- Firm FEI
- 3003604053
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28