CLASS II ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report
LinkSymphoKnee System, Tibial Component, Modular, Symmetric recalled
Waldemar Link GmbH & Co. KG (Mfg Site) is recalling LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, distributed nationwide in the US. The recall was initiated on 31 Jul 2025 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-2541-2025
- FDA event ID
- 97383
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Jul 2025
- FDA classified
- 8 Sep 2025
- Reported
- 17 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 31 Jul 2025 | Recall initiated by company | |
| 8 Sep 2025 | Classified by FDA | +39 days |
| 17 Sep 2025 | 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
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Product as listed by the FDA
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Where it was distributed
Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.
Questions about this recall
Why was it recalled?
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Which lots are affected?
REF Number: 880-100/50. UDI-DI: 04026575251278. Serial Numbers: 210125/2259, 210125/2262, 210125/2268, 210125/2260, 210125/2264, 210125/2270, 210125/2272, 210125/2273.
Where was it sold?
Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.
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.
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) | Other | 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 Hip & Knee Implants recalls
All 3,110| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |
| Device | CLASS II | Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled | Howmedica Osteonics | Other | Nationwide |