Waldemar Link GmbH & Co. KG (Mfg Site): 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)

Hazard

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

Details from the source

Reason for recall: The device was delivered with a preassembled Femoral Augment screw that was missing its thread. Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI. Quantity: 441 units Lot/code info: 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.

UPC codes

04026575258048, 04026575258055, 04026575258062, 04026575258079, 04026575258086, 04026575258109, 04026575258123, 04026575258147, 04026575258154, 04026575258161, 04026575258178, 04026575258185

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.