medical MODERATE Updated 2023-06-07

Linkbio Corp. recalls LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Righ

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Recalled Product

LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13

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Hazard / Issue

Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI : 04026575258123 Lot Number: 1910003

✅ 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.
View official government recall