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Recall Observatory FDA recall evidence

Device product

Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm

Z-2045-2017

March 24, 2017

Class II

Product summary

Firm
Arthrex, Inc.
Event
Event 76986
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2045-2017

Official wording

Reason: Some eyelets broke from SwiveLock Anchor on insertion.

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

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)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some eyelets broke from SwiveLock Anchor on insertion.