Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7) 880-313/21 (Sz. 3-4 - cemented lg), (8) 880-313/22 (Sz. 3-4 - cemented x-lg), (9) 880-315/11 (Sz. 5-6 - cemented sm), (10) 880-315/12 (Sz. 5-6 - cemented md), (11) 880-315/21 (Sz. 5-6 - cemented lg), (12) 880-315/22 (Sz. 5-6 - cemented x-lg), (13) 880-317/11 (Sz. 7-8 - cemented sm), (14) 880-317/12 (Sz. 7-8 - cemented md), (15) 880-317/21 (Sz. 7-8 - cemented lg), (16) 880-317/22 (Sz. 7-8 - cemented x-lg), (17) 880-319/11 (Sz. 9-10 - cemented sm), (18) 880-319/12 (Sz. 9-10 - cemented md), (19) 880-319/21 (Sz. 9-10 - cemented lg), (20) 880-319/22 (Sz. 9-10 - cemented x-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?

Check if you have this product:
Item Number/UDI-DI: (1) 880-310/11 (04026575257539), (2) 880-310/21 (04026575257546), (3) 880-311/11 (04026575257607), (4) 880-311/21 (04026575257584), (5) 880-313/11 (04026575257621), (6) 880-313/12 (04026575257645), (7) 880-313/21 (04026575257669), (8) 880-313/22 (04026575257690), (9) 880-315/11 (04026575257768), (10) 880-315/12 (04026575257775), (11) 880-315/21 (04026575257782), (12) 880-315/22 (04026575257799), (13) 880-317/11 (04026575257843), (14) 880-317/12 (04026575257850), (15) 880-317/21 (04026575257867), (16) 880-317/22 (04026575257881), (17) 880-319/11 (04026575257942), (18) 880-319/12 (04026575257959), (19) 880-319/21 (04026575257966), (20) 880-319/22 (04026575257973). Applies to all lots of the LINK SymphoKnee Femoral Augments listed, manufactured up until 03/01/2025.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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:

Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7) 880-313/21 (Sz. 3-4 - cemented lg), (8) 880-313/22 (Sz. 3-4 - cemented x-lg), (9) 880-315/11 (Sz. 5-6 - cemented sm), (10) 880-315/12 (Sz. 5-6 - cemented md), (11) 880-315/21 (Sz. 5-6 - cemented lg), (12) 880-315/22 (Sz. 5-6 - cemented x-lg), (13) 880-317/11 (Sz. 7-8 - cemented sm), (14) 880-317/12 (Sz. 7-8 - cemented md), (15) 880-317/21 (Sz. 7-8 - cemented lg), (16) 880-317/22 (Sz. 7-8 - cemented x-lg), (17) 880-319/11 (Sz. 9-10 - cemented sm), (18) 880-319/12 (Sz. 9-10 - cemented md), (19) 880-319/21 (Sz. 9-10 - cemented lg), (20) 880-319/22 (Sz. 9-10 - cemented x-lg).

Product Codes/Lot Numbers:

Item Number/UDI-DI: (1) 880-310/11 (04026575257539), (2) 880-310/21 (04026575257546), (3) 880-311/11 (04026575257607), (4) 880-311/21 (04026575257584), (5) 880-313/11 (04026575257621), (6) 880-313/12 (04026575257645), (7) 880-313/21 (04026575257669), (8) 880-313/22 (04026575257690), (9) 880-315/11 (04026575257768), (10) 880-315/12 (04026575257775), (11) 880-315/21 (04026575257782), (12) 880-315/22 (04026575257799), (13) 880-317/11 (04026575257843), (14) 880-317/12 (04026575257850), (15) 880-317/21 (04026575257867), (16) 880-317/22 (04026575257881), (17) 880-319/11 (04026575257942), (18) 880-319/12 (04026575257959), (19) 880-319/21 (04026575257966), (20) 880-319/22 (04026575257973). 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-1700-2025

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