medical MODERATE Updated 2017-11-29

Exactech, Inc. recalls Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T,

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Recalled Product

Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.

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Hazard / Issue

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Issued by

FDA

Affected States: AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA
Lot/Code Info: All lot numbers

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

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