CLASS II ONGOING Device recall · Reported 12 Jul 2023 · FDA Enforcement Report

LinkSymphoKnee Distal Femoral Augment - Tilastan - Size recalled

Waldemar Link GmbH & Co. KG (Mfg Site) is recalling LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, distributed nationwide in the US. The recall was initiated on 23 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 04026575257379 Lot Number: 2123225

Quantity recalled20 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2066-2023
FDA event ID: 92496
Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 23 Dec 2022
FDA classified: 3 Jul 2023
Reported: 12 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

23 Dec 2022	Recall initiated by company
3 Jul 2023	Classified by FDA	+192 days
12 Jul 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.

Nationwide Alabama Georgia Illinois Indiana Louisiana Nevada Texas

Questions about this recall

Why was it recalled?

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).

Which lots are affected?

UDI-DI: 04026575257379 Lot Number: 2123225

Where was it sold?

US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 92496

This product is part of a recall event; the main page for the event is LinkSymphoKnee Distal Femoral Augment - Tilastan - Size recalled.

Reported	Class	Recall	Company	Reason	Where
12 Jul 2023	CLASS II	LinkSymphoKnee Distal Femoral Augment - Tilastan - Size recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	Nationwide

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
1 Apr 2026Device	CLASS II	Embrace Drill Tower, Standard/Lateral recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	15 states
1 Apr 2026Device	CLASS II	Embrace Drill Tower, Wedged recalled by Waldemar Link GmbH & Co. KG	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	15 states
18 Mar 2026Device	CLASS II	Endo-Model Replacement Plateau; Item Number: 15-0027/16 recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	Nationwide
18 Mar 2026Device	CLASS II	Endo-Model Replacement Plateau; Item Number: 15-0027/12 recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide