Waldemar Link GmbH & Co. KG (Mfg Site): Medical Device Recall in 2025 - (Recall #: Z-1701-2025)

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:

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 Classification:

Class II

Date Initiated: April 3, 2025

Date Posted: May 7, 2025

Recall Number: Z-1701-2025

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: 441 units

Code Information:

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.

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