FDAClass IIMay 17, 2017

Anthrex SpeedBridge Implant System with PEEK SwiveLock recall

Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching

Why was Anthrex SpeedBridge Implant System with PEEK SwiveLock 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: 00888867160231 Batch Number: 10070003 - Expiration Date 9/30/2021

Product
Anthrex SpeedBridge Implant System with PEEK SwiveLock 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