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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Arthrex, Inc.
Reason for Recall:
Some eyelets broke from SwiveLock Anchor on insertion.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2045-2017

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