Z-0724-2019Class II

Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including...

Name: Z-0724-2019 Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including...
Creator: Arthrex, Inc.
Published: 2018-11-19
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2018-11-19 / Open, Classified / root cause: manufacturing process

FDA source

Arthrex, Inc. began a recall of Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product... on 2018-11-19. FDA classified it as Class II and gives the reason as "Potentially lead to anchor breakage during insertion". 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-0724-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-11-19
Posted: 2019-01-11
Recalling firm: Arthrex GmbH
Product: Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Potentially lead to anchor breakage during insertion,
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On November 19, 2018 Arthrex sent communications to their customers indicating the following about their recall: REQUIRED ACTION BY RECIPIENT 1. Immediately discontinue use, sale, and distribution of the affected product. 2. Please contact Arthrex Product Surveillance at 866-267-9138 or complai [email protected] (for direct Customers); contact [email protected] (for Agencies) as soon as possible to arrange for return of the affected product. Our Product Surveillance Specialists can provide assistance regarding alternative solutions and are available to answer questions regarding credit for affected devices in your possession. 3. If you are an Arthrex agency, you do not need to notify any customers as Arthrex will be notifying customers directly. 4. If you are an Arthrex customer, you do not need to notify any patients of this product recall. 5. If you have any questions about this product recall, please contact Arthrex Product Surveillance at 866-267-9138 or [email protected].
Quantity in commerce: 1308 US and 110 OUS
Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of Finland and Germany
Product codes and lots: Lots #: 10175216, 1075219, 10199557, and 10199558

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0724-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0724-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-01-23	2019-01-11

Product code MBI

K180118Class IIArthrex NanoSuture AnchorArthrex, Inc. / cleared 2018-02-12

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)