Waldemar Link GmbH & Co. KG (Mfg Site): Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 88

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: 1180 units Lot/code info: Item Number/UDI-DI: (1) 880-300/11 (04026575284931), (2) 880-300/21 (04026575257102), (3) 880-301/11 (04026575257133), (4) 880-301/21 (04026575257140), (5) 880-303/11 (04026575257171), (6) 880-303/12 (04026575257188), (7) 880-303/21 (04026575257195), (8) 880-303/22 (04026575257201), (9) 880-305/11 (04026575257256), (10) 880-305/12 (04026575257263), (11) 880-305/21 (04026575257270), (12) 880-305/22 (04026575257287), (13) 880-307/11 (04026575257379), (14) 880-307/12 (04026575257386), (15) 880-307/21 (04026575257393), (16) 880-307/22 (04026575257409), (17) 880-309/11 (04026575257454), (18) 880-309/12 (04026575257461), (19) 880-309/21 (04026575257478), (20) 880-309/22 (04026575257485). Applies to all lots of the LINK SymphoKnee Femoral Augments listed, manufactured up until 03/01/2025.

UPC codes

04026575284931, 04026575257102, 04026575257133, 04026575257140, 04026575257171, 04026575257188, 04026575257195, 04026575257201, 04026575257256, 04026575257263, 04026575257270, 04026575257287, 04026575257379, 04026575257386, 04026575257393, 04026575257409, 04026575257454, 04026575257461, 04026575257478, 04026575257485

Source

Official record: FDA (Device enforcement) ↗

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