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

Recall Details

Recall Number

Z-1702-2025

Classification

Class II

Product Type

Device

Recalling Firm

Waldemar Link GmbH & Co. KG (Mfg Site)

Status

Ongoing

Date Initiated

04/03/2025

Location

Norderstedt, N/A, Germany

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1771 units

Reason for Recall

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

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);

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.

Other Recalls by Waldemar Link GmbH & Co. KG (Mfg Site)

• Class II: Risk 11/10/2025
  The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
• Class II: Risk 07/31/2025
  Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
• Class II: Risk 07/15/2025
  Inconsistent size terminology and color coding used on labeling
• Class II: Risk 07/15/2025
  Inconsistent size terminology and color coding used on labeling
• Class II: Risk 04/03/2025
  The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

View all recalls by Waldemar Link GmbH & Co. KG (Mfg Site) →