Waldemar Link GmbH & Co. KG (Mfg Site): Medical Device Recall in 2025 - (Recall #: Z-1702-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product 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 Classification:

Class II

Date Initiated: April 3, 2025

Date Posted: May 7, 2025

Recall Number: Z-1702-2025

Event ID: 96643

Reason for Recall:

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

Status: Ongoing

Product Quantity: 1771 units

Code Information:

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.

Distribution Pattern:

US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI.

Voluntary or Mandated:

Voluntary: Firm initiated