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Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0...

FDA Recall #Z-1699-2025 — Class II — April 3, 2025

Recall #Z-1699-2025 Date: April 3, 2025 Classification: Class II Status: Ongoing

Product Description

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) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 880-303/21 (Sz. 3-4 - cemented lg), (8) 880-303/22 (Sz. 3-4 - cemented x-lg), (9) 880-305/11 (Sz. 5-6 - cemented sm), (10) 880-305/12 (Sz. 5-6 - cemented md), (11) 880-305/21 (Sz. 5-6 - cemented lg), (12) 880-305/22 (Sz. 5-6 - cemented x-lg), (13) 880-307/11 (Sz. 7-8 - cemented sm), (14) 880-307/12 (Sz. 7-8 - cemented md), (15) 880-307/21 (Sz. 7-8 - cemented lg), (16) 880-307/22 (Sz. 7-8 - cemented x-lg), (17) 880-309/11 (Sz. 9-10 - cemented sm), (18) 880-309/12 (Sz. 9-10 - cemented md), (19) 880-309/21 (Sz. 9-10 - cemented lg), (20) 880-309/22 (Sz. 9-10 - cemented x-lg).

Reason for Recall

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

Recalling Firm

Waldemar Link GmbH & Co. KG (Mfg Site) — Norderstedt, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1180 units

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.

Code Information

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.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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