RecallRadar

FDA Device recall Z-2043-2017

Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching

On 2017-05-17 the FDA classified a Class II recall of Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching by Arthrex, citing some eyelets broke from SwiveLock Anchor on insertion.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2043-2017
ClassificationClass II
Statusterminated
Initiated2017-03-24
Published2017-05-17
Last updated2026-09-13 11:54 UTC
CompanyArthrex
DistributionAK, 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 Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching

Reason

Some eyelets broke from SwiveLock Anchor on insertion.

Identifiers

code_info
Unique Device Identifier: 00888867026865 Batch Number: 10072425 - Expiration Date 10/31/2018 Batch Number: 10073992 -…Unique Device Identifier: 00888867026865 Batch Number: 10072425 - Expiration Date 10/31/2018 Batch Number: 10073992 - Expiration Date 10/31/2018 Batch Number: 10077133 - Expiration Date 10/31/2018 Batch Number: 10078077 - Expiration Date 11/30/2018 Batch Number: 10078340 - Expiration Date 11/30/2018 Batch Number: 10075792 - Expiration Date 10/31/2018

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-2043-2017%22

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