Z-1702-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 7, 2025
- Initiation Date
- April 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1771 units
Product Description
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) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7) 880-333/11 (Sz. 3-4 - cemented x-sm), (8) 880-333/12 (Sz. 3-4 - cemented sm), (9) 880-333/13 (Sz. 3-4 - cemented md), (10) 880-333/21 (Sz. 3-4 - cemented lg), (11) 880-333/22 (Sz. 3-4 - cemented x-lg), (12) 880-333/23 (Sz. 3-4 - cemented xx-lg), (13) 880-335/11 (Sz. 5-6 - cemented x-sm), (14) 880-335/12 (Sz. 5-6 - cemented sm), (15) 880-335/13 (Sz. 5-6 - cemented md), (16) 880-335/21 (Sz. 5-6 - cemented lg), (17) 880-335/22 (Sz. 5-6 - cemented lg), (18) 880-335/23 (Sz. 5-6 - cemented xx-lg), (19) 880-337/11 (Sz. 7-8 - cemented x-sm), (20) 880-337/12 (Sz. 5-6 - cemented sm), (21) 880-337/13 (Sz. 7-8 - cemented md), (22) 880-337/21 (Sz. 7-8 - cemented lg), (23) 880-337/22 (Sz. 7-8 - cemented x-lg), (24) 880-337/23 (Sz. 7-8 - cemented xx-lg), (25) 880-339/11 (Sz. 9-10 - cemented x-sm), (26) 880-339/12 (Sz. 9-10 - cemented sm), (27) 880-339/13 (Sz. 9-10 - cemented md), (28) 880-339/21 (Sz. 9-10 - cemented lg), (29) 880-339/22 (Sz. 9-10 - cemented x-lg), (30) 880-339/23 (Sz. 9-10 - cemented xx-lg);
Reason for Recall
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
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.
Code Information
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.