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

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: 908 units Lot/code info: 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.

UPC codes

04026575257539, 04026575257546, 04026575257607, 04026575257584, 04026575257621, 04026575257645, 04026575257669, 04026575257690, 04026575257768, 04026575257775, 04026575257782, 04026575257799, 04026575257843, 04026575257850, 04026575257867, 04026575257881, 04026575257942, 04026575257959, 04026575257966, 04026575257973

Source

Official record: FDA (Device enforcement) ↗

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