Z-2746-2020Class II

SUTUREFIX ULTRA Suture, Product number 72203855

Name: Z-2746-2020 SUTUREFIX ULTRA Suture, Product number 72203855
Creator: Smith & Nephew, Inc.
Published: 2020-06-24
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2020-06-24 / Open, Classified / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of SUTUREFIX ULTRA Suture, Product number 72203855 on 2020-06-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2746-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-06-24
Posted: 2020-07-31
Recalling firm: Smith & Nephew, Inc.
Product: SUTUREFIX ULTRA Suture, Product number 72203855
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
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.
Root cause tag: manufacturing process
FDA 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 [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].
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
Product codes and lots: Lot numbers 2038366, 2039311 and 2046505

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2746-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2746-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-12	2020-07-31

Product code MBI

K122059Class IIAll-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture AnchorsSmith & Nephew, Inc. / cleared 2013-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)