Z-2107-2021Class II

Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC

Name: Z-2107-2021 Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Creator: Arthrex, Inc.
Published: 2021-06-14
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2021-06-14 / Open, Classified / root cause: packaging

FDA source

Arthrex, Inc. began a recall of Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC on 2021-06-14. FDA classified it as Class II and gives the reason as "Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2107-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-14
Posted: 2021-07-21
Recalling firm: Arthrex GmbH
Product: Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Product code: MAI Fastener, Fixation, Biodegradable, Soft Tissue
Reason for recall: Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On June 14, 2021 the firm e-mail their consignees with the following instructions: Immediately discontinue use, sale, and distribution of the affected lots of product. and to contact the Field Logistics Services at [email protected] to answer questions regarding credit for affected devices in your possession.
Quantity in commerce: 3985 pieces
Distribution: US Nationwide Distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Hawaii.
Product codes and lots: Lots 12758314 and 13022357

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2107-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2107-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-21

Product code MAI

K203495Class IIArthrex SwiveLock AnchorArthrex, Inc. / cleared 2021-04-19

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)