Z-2045-2017 Class II Terminated
FDA device recall Z-2045-2017 was initiated by Arthrex, Inc. on March 24, 2017 and is designated Class II. Reason for recall: Some eyelets broke from SwiveLock Anchor on insertion. The recall status is terminated (terminated November 4, 2019). Affected quantity: N/A.
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 SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
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: 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