CLASS II ONGOING Device recall · Reported 18 Mar 2026 · FDA Enforcement Report
Endo-Model SL Connection Component incl. PE-Plateau; Item Number recalled
Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Endo-Model SL Connection Component incl. PE-Plateau; Item Number, distributed nationwide in the US. The recall was initiated on 12 Jan 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-1514-2026
- FDA event ID
- 98342
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Jan 2026
- FDA classified
- 10 Mar 2026
- Reported
- 18 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Jan 2026 | Recall initiated by company | |
| 10 Mar 2026 | Classified by FDA | +57 days |
| 18 Mar 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 potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Product as listed by the FDA
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Where it was distributed
Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
Questions about this recall
Is Endo-Model SL Connection Component incl. PE-Plateau; Item Number recalled?
Yes. Waldemar Link GmbH & Co. KG (Mfg Site) recalled Endo-Model SL Connection Component incl. PE-Plateau; Item Number on 12 Jan 2026. The recall is Class II and its status is Ongoing. Recall number Z-1514-2026.
Why was it recalled?
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Which lots are affected?
Item Number: 16-2840/07; UDI-DI: 04026575359257; Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489 , 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345 , 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356 , 250925/0369, 250925/0501, 250925/0365, 250925/0368, 250925/0490, 250925/0488 , 250925/0479, 250925/0495, 250925/0500, 250925/0496, 250925/0499, 250925/0367;
Where was it sold?
Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
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 | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| 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 |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |