CLASS II ONGOING Device recall · Reported 20 Jul 2022 · FDA Enforcement Report

Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02) recalled

Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), distributed in 15 states. The recall was initiated on 24 May 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 04026575316281 (Small) 04026575316298 (Medium) 04026575316304 (Large) Serial/Lot Numbers: 210420/0762 210426/0311 210426/0363 210426/0364 210426/0374 210504/2485 210504/2552 210504/2564 210504/2566 210510/2845 210510/2846 210602/0215 210602/0265 210602/0266 210602/1068 210602/2717 210602/2721 210602/2733 210602/2769 210629/0893 210629/0919 210629/0929 210629/0967 210629/0969 210629/1046 210629/1051 210629/1054 210629/2750 210802/0663 210802/0771 210802/0841 210907/2316 210907/2317 210913/0613 210913/0622 210913/0762 210913/0797 210913/0801 210913/0809 210913/2167 211025/0391 211025/2541 211025/2543 211025/2563 211102/0426 211102/0431 211115/0220 211115/1948 211115/2111

Quantity recalled3785

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-1377-2022
FDA event ID: 90477
Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt
Classification: Class II
Status: Ongoing
Recall initiated: 24 May 2022
FDA classified: 12 Jul 2022
Reported: 20 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Lead & Heavy Metals
Device type: Hip & Knee Implants

Timeline

24 May 2022	Recall initiated by company
12 Jul 2022	Classified by FDA	+49 days
20 Jul 2022	Published in enforcement report	+8 days

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

Reason for recall

There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.

Where it was distributed

Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France Germany Great Britain Greece Hungary India Indonesia Israel Italy Latvia Libya Lithuania Mexico Netherlands Norway Pakistan Peru Philippines Poland Romania Saudi Arabia Slovakia Slovenia Spain Sudan Sweden Switzerland Thailand Turkey Ukraine United Arab Emirates Uruguy Vietnam

Alabama California Florida Georgia Illinois Indiana Kansas Michigan Minnesota Nevada New York Ohio Tennessee Texas Washington

Questions about this recall

Is Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02) recalled?

Yes. Waldemar Link GmbH & Co. KG (Mfg Site) recalled Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02) on 24 May 2022. The recall is Class II and its status is Ongoing. Recall number Z-1377-2022.

Why was it recalled?

There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.

Which lots are affected?

UDI-DI 04026575316281 (Small) 04026575316298 (Medium) 04026575316304 (Large) Serial/Lot Numbers: 210420/0762 210426/0311 210426/0363 210426/0364 210426/0374 210504/2485 210504/2552 210504/2564 210504/2566 210510/2845 210510/2846 210602/0215 210602/0265 210602/0266 210602/1068 210602/2717 210602/2721 210602/2733 210602/2769 210629/0893 210629/0919 210629/0929 210629/0967 210629/0969 210629/1046 210629/1051 210629/1054 210629/2750 210802/0663 210802/0771 210802/0841 210907/2316 210907/2317 210913/0613 210913/0622 210913/0762 210913/0797 210913/0801 210913/0809 210913/2167 211025/0391 211025/2541 211025/2543 211025/2563 211102/0426 211102/0431 211115/0220 211115/1948 211115/2111

Where was it sold?

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

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)	Lead & Heavy Metals	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

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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)	Lead & Heavy Metals	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide