Z-2045-2017Class II

Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm

Name: Z-2045-2017 Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Creator: Arthrex, Inc.
Published: 2017-03-24
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2017-03-24 / Terminated

FDA source

Arthrex, Inc. began a recall of Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm on 2017-03-24. FDA classified it as Class II and gives the reason as "Some eyelets broke from SwiveLock Anchor on insertion". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2045-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-24
Posted: 2017-05-05
Terminated: 2019-11-04
Recalling firm: Arthrex GmbH
Product: Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Product code: MAI Fastener, Fixation, Biodegradable, Soft Tissue
Reason for recall: Some eyelets broke from SwiveLock Anchor on insertion.
FDA root cause: Under Investigation by firm
Action: On March 24, 2017, Arthrex contacted all distributors that received potentially affected device and instructed them to place the product in quarantine. On March 27th, 2017, Distributors were instructed to return the affected device to Arthrex. Call Arthrex Customer Service at 855-552-5056 for returned goods authorization (RGA) and product return instruction. Please complete the Recall Acknowledge of Receipt postal card included in the notification. Any questions contact [email protected] 866-267-9138
Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)
Product codes and lots: Unique Device Identifier: 00888867027329 Batch Number: 10072597 - Expiration Date 10/31/2018 Batch Number: 10074288 - Expiration Date 10/31/2018 Batch Number: 10076753 - Expiration Date 10/31/2018 Batch Number: 10076852 - Expiration Date 10/31/2018 Batch Number: 10081420 - Expiration Date 11/30/2018 Batch Number: 10075965 - Expiration Date 10/31/2018 Batch Number: 10077252 - Expiration Date 10/31/2018 Batch Number: 10084027 - Expiration Date 12/31/2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2045-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2041-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-05
Z-2042-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-05
Z-2043-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-05
Z-2044-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-05
Z-2045-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-05
Z-2046-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-05

Product code MAI

K101823Class IIArthrex Swivelock AnchorsArthrex, Inc. / cleared 2011-01-07

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)