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

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: 1771 units Lot/code info: 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.

UPC codes

04026575258192, 04026575258208, 04026575258215, 04026575258222, 04026575258246, 04026575258253, 04026575258260, 04026575258277, 04026575258284, 04026575258291, 04026575258307, 04026575258314, 04026575258321, 04026575258338, 04026575258345, 04026575258352, 04026575258369, 04026575258376, 04026575258383, 04026575258390, 04026575258406, 04026575258413, 04026575258420, 04026575258437, 04026575258475, 04026575258505, 04026575258529, 04026575258536, 04026575258543, 04026575258550

Source

Official record: FDA (Device enforcement) ↗

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