FDAClass IIMay 17, 2017

Anthrex Bio-SwiveLock SP Vented recall

Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

Why was Anthrex Bio-SwiveLock SP Vented recalled?

Some eyelets broke from SwiveLock Anchor on insertion.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Unique Device Identifier: 00888867026766 Batch Number: 1078259 Expiration Date 11/30/2018

Product
Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Recalling firm
Arthrex, Inc.
Quantity
N/A
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)
Recall date
May 17, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls