FDA Device recall Z-2045-2017

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

FDA Device
Class II
terminated
Published 2017-05-17

On 2017-05-17 the FDA classified a Class II recall of Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm by Arthrex, citing some eyelets broke from SwiveLock Anchor on insertion.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2045-2017
Classification	Class II
Status	terminated
Initiated	2017-03-24
Published	2017-05-17
Last updated	2026-09-13 11:54 UTC
Company	Arthrex
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, PR, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY

Product

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

Reason

Some eyelets broke from SwiveLock Anchor on insertion.

Identifiers

code_info	Unique Device Identifier: 00888867027329 Batch Number: 10072597 - Expiration Date 10/31/2018 Batch Number: 10074288 -… 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

code_info

Unique Device Identifier: 00888867027329 Batch Number: 10072597 - Expiration Date 10/31/2018 Batch Number: 10074288 -…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2045-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.