Recall Z-2066-2023— Waldemar Link GmbH & Co. KG (Mfg Site)
Class II · Ongoing
Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Mfg Site), initiated 2022-12-23. It names one FDA 510(k) clearance: K202924. Product: LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11. Reason: Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation)..
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-23
- Firm location
- Norderstedt, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
Reason for recall
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
Data sourced from openFDA. This site is unofficial and independent of the FDA.