Z-2043-2017 Class II Terminated

Recalled by Arthrex, Inc. — Naples, FL

Recall Details

Product Type
Devices
Report Date
May 17, 2017
Initiation Date
March 24, 2017
Termination Date
November 4, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

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

Reason for Recall

Some eyelets broke from SwiveLock Anchor on insertion.

Distribution Pattern

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)

Code Information

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