CLASS II ONGOING Device recall · Reported 19 Aug 2026 · FDA Enforcement Report
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled
Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe, distributed in Indiana. The recall was initiated on 6 Jul 2026 and the FDA has classified it as Class II.
Check your package
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-2934-2026
- FDA event ID
- 99405
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Jul 2026
- FDA classified
- 11 Aug 2026
- Reported
- 19 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Hip & Knee Implants
Timeline
| 6 Jul 2026 | Recall initiated by company | |
| 11 Aug 2026 | Classified by FDA | +36 days |
| 19 Aug 2026 | 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
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
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, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Where it was distributed
Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
Questions about this recall
Is Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled?
Yes. Waldemar Link GmbH & Co. KG (Mfg Site) recalled Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe on 6 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-2934-2026.
Why was it recalled?
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
Which lots are affected?
UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
Where was it sold?
Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
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.
More recalls from Waldemar Link GmbH & Co. KG (Mfg Site)
All 65| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Embrace Drill Tower, Standard/Lateral recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | 15 states |
| Device | CLASS II | Embrace Drill Tower, Wedged recalled by Waldemar Link GmbH & Co. KG | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | 15 states |
| Device | CLASS II | Endo-Model Replacement Plateau; Item Number: 15-0027/16 recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | Nationwide |
| Device | CLASS II | Endo-Model Replacement Plateau; Item Number: 15-0027/12 recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | Nationwide |
| Device | CLASS II | Endo-Model Replacement Plateau; Item Number: 15-8521/11 recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | Nationwide |
Other Hip & Knee Implants recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |
| Device | CLASS II | U2 Total Knee System Femoral valgus offset adaptor, left recalled | United Orthopedic | Device Malfunction | Nationwide |