🔍 RecallPedia

L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7) 880-325/13 (Sz. 5-6 - cemented sm), (8) 880-325/23 (Sz. 5-6 - cemented lg), (9) 880-327/13 (Sz. 7-8 - cemented sm), (10) 880-327/23 (Sz. 7-8 - cemented lg), (11) 880-329/13 (Sz. 9-10 - cemented sm), (12) 880-329/23 (Sz. 9-10 - cemented lg).

Class I - Dangerous
🏥 Medical Devices Recalled: April 3, 2025 Waldemar Link GmbH & Co. KG (Mfg Site) Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Item Number/UDI-DI: (1) 880-320/12 (04026575258048), (2) 880-320/22 (04026575258055), (3) 880-321/12 (04026575258062), (4) 880-321/22 (04026575258079), (5) 880-323/13 (04026575258086), (6) 880-323/23 (04026575258109), (7) 880-325/13 (04026575258123), (8) 880-325/23 (04026575258147), (9) 880-327/13 (04026575258154), (10) 880-327/23 (04026575258161), (11) 880-329/13 (04026575258178), (12) 880-329/23 (04026575258185). Applies to all lots of the LINK SymphoKnee Femoral Augments listed, manufactured up until 03/01/2025.
  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:
Waldemar Link GmbH & Co. KG (Mfg Site)
Reason for Recall:
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7) 880-325/13 (Sz. 5-6 - cemented sm), (8) 880-325/23 (Sz. 5-6 - cemented lg), (9) 880-327/13 (Sz. 7-8 - cemented sm), (10) 880-327/23 (Sz. 7-8 - cemented lg), (11) 880-329/13 (Sz. 9-10 - cemented sm), (12) 880-329/23 (Sz. 9-10 - cemented lg).

Product Codes/Lot Numbers:

Item Number/UDI-DI: (1) 880-320/12 (04026575258048), (2) 880-320/22 (04026575258055), (3) 880-321/12 (04026575258062), (4) 880-321/22 (04026575258079), (5) 880-323/13 (04026575258086), (6) 880-323/23 (04026575258109), (7) 880-325/13 (04026575258123), (8) 880-325/23 (04026575258147), (9) 880-327/13 (04026575258154), (10) 880-327/23 (04026575258161), (11) 880-329/13 (04026575258178), (12) 880-329/23 (04026575258185). Applies to all lots of the LINK SymphoKnee Femoral Augments listed, manufactured up until 03/01/2025.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1701-2025

Related Recalls

Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

Feb 11, 2026 Other Medical Devices View Details →