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High RiskFDAfda-Z-2045-2017OTHER

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

Units Affected
0
Recall Date
March 24, 2017
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2045-2017.

Some eyelets broke from SwiveLock Anchor on insertion.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2045-2017.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Arthrex, Inc. or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2045-2017.

Arthrex, Inc.

FDA

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Arthrex, Inc. Recall FAQ

Arthrex, Inc. is the subject of a medical implants safety report: Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm. The notice was published on March 24, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 0 units are potentially affected.