Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7) 880-333/11 (Sz. 3-4 - cemented x-sm), (8) 880-333/12 (Sz. 3-4 - cemented sm), (9) 880-333/13 (Sz. 3-4 - cemented md), (10) 880-333/21 (Sz. 3-4 - cemented lg), (11) 880-333/22 (Sz. 3-4 - cemented x-lg), (12) 880-333/23 (Sz. 3-4 - cemented xx-lg), (13) 880-335/11 (Sz. 5-6 - cemented x-sm), (14) 880-335/12 (Sz. 5-6 - cemented sm), (15) 880-335/13 (Sz. 5-6 - cemented md), (16) 880-335/21 (Sz. 5-6 - cemented lg), (17) 880-335/22 (Sz. 5-6 - cemented lg), (18) 880-335/23 (Sz. 5-6 - cemented xx-lg), (19) 880-337/11 (Sz. 7-8 - cemented x-sm), (20) 880-337/12 (Sz. 5-6 - cemented sm), (21) 880-337/13 (Sz. 7-8 - cemented md), (22) 880-337/21 (Sz. 7-8 - cemented lg), (23) 880-337/22 (Sz. 7-8 - cemented x-lg), (24) 880-337/23 (Sz. 7-8 - cemented xx-lg), (25) 880-339/11 (Sz. 9-10 - cemented x-sm), (26) 880-339/12 (Sz. 9-10 - cemented sm), (27) 880-339/13 (Sz. 9-10 - cemented md), (28) 880-339/21 (Sz. 9-10 - cemented lg), (29) 880-339/22 (Sz. 9-10 - cemented x-lg), (30) 880-339/23 (Sz. 9-10 - cemented xx-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) 880-331/11 (04026575258192), (2) 880-331/12 (04026575258208), (3) 880-331/13 (04026575258215), (4) 880-331/21 (04026575258222), (5) 880-331/22 (04026575258246), (6) 880-331/23 (04026575258253), (7) 880-333/11 (04026575258260), (8) 880-333/12 (04026575258277), (9) 880-333/13 (04026575258284), (10) 880-333/21 (04026575258291), (11) 880-333/22 (04026575258307), (12) 880-333/23 (04026575258314), (13) 880-335/11 (04026575258321), (14) 880-335/12 (04026575258338), (15) 880-335/13 (04026575258345), (16) 880-335/21 (04026575258352), (17) 880-335/22 (04026575258369), (18) 880-335/23 (04026575258376), (19) 880-337/11 (04026575258383), (20) 880-337/12 (04026575258390), (21) 880-337/13 (04026575258406), (22) 880-337/21 (04026575258413), (23) 880-337/22 (04026575258420), (24) 880-337/23 (04026575258437), (25) 880-339/11 (04026575258475), (26) 880-339/12 (04026575258505), (27) 880-339/13 (04026575258529), (28) 880-339/21 (04026575258536), (29) 880-339/22 (04026575258543), (30) 880-339/23 (04026575258550); 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:

Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7) 880-333/11 (Sz. 3-4 - cemented x-sm), (8) 880-333/12 (Sz. 3-4 - cemented sm), (9) 880-333/13 (Sz. 3-4 - cemented md), (10) 880-333/21 (Sz. 3-4 - cemented lg), (11) 880-333/22 (Sz. 3-4 - cemented x-lg), (12) 880-333/23 (Sz. 3-4 - cemented xx-lg), (13) 880-335/11 (Sz. 5-6 - cemented x-sm), (14) 880-335/12 (Sz. 5-6 - cemented sm), (15) 880-335/13 (Sz. 5-6 - cemented md), (16) 880-335/21 (Sz. 5-6 - cemented lg), (17) 880-335/22 (Sz. 5-6 - cemented lg), (18) 880-335/23 (Sz. 5-6 - cemented xx-lg), (19) 880-337/11 (Sz. 7-8 - cemented x-sm), (20) 880-337/12 (Sz. 5-6 - cemented sm), (21) 880-337/13 (Sz. 7-8 - cemented md), (22) 880-337/21 (Sz. 7-8 - cemented lg), (23) 880-337/22 (Sz. 7-8 - cemented x-lg), (24) 880-337/23 (Sz. 7-8 - cemented xx-lg), (25) 880-339/11 (Sz. 9-10 - cemented x-sm), (26) 880-339/12 (Sz. 9-10 - cemented sm), (27) 880-339/13 (Sz. 9-10 - cemented md), (28) 880-339/21 (Sz. 9-10 - cemented lg), (29) 880-339/22 (Sz. 9-10 - cemented x-lg), (30) 880-339/23 (Sz. 9-10 - cemented xx-lg);

Product Codes/Lot Numbers:

Item Number/UDI-DI: (1) 880-331/11 (04026575258192), (2) 880-331/12 (04026575258208), (3) 880-331/13 (04026575258215), (4) 880-331/21 (04026575258222), (5) 880-331/22 (04026575258246), (6) 880-331/23 (04026575258253), (7) 880-333/11 (04026575258260), (8) 880-333/12 (04026575258277), (9) 880-333/13 (04026575258284), (10) 880-333/21 (04026575258291), (11) 880-333/22 (04026575258307), (12) 880-333/23 (04026575258314), (13) 880-335/11 (04026575258321), (14) 880-335/12 (04026575258338), (15) 880-335/13 (04026575258345), (16) 880-335/21 (04026575258352), (17) 880-335/22 (04026575258369), (18) 880-335/23 (04026575258376), (19) 880-337/11 (04026575258383), (20) 880-337/12 (04026575258390), (21) 880-337/13 (04026575258406), (22) 880-337/21 (04026575258413), (23) 880-337/22 (04026575258420), (24) 880-337/23 (04026575258437), (25) 880-339/11 (04026575258475), (26) 880-339/12 (04026575258505), (27) 880-339/13 (04026575258529), (28) 880-339/21 (04026575258536), (29) 880-339/22 (04026575258543), (30) 880-339/23 (04026575258550); 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-1702-2025

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