CLASS II ONGOING Device recall · Reported 6 Mar 2024 · FDA Enforcement Report
LINK BiMobile Dual Mobility System E-Poly Liner recalled
Waldemar Link GmbH & Co. KG (Mfg Site) is recalling LINK BiMobile Dual Mobility System E-Poly Liner for Head Shell- Indicated for patients, distributed nationwide in the US. The recall was initiated on 22 Jan 2024 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-1219-2024
- FDA event ID
- 93944
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Jan 2024
- FDA classified
- 29 Feb 2024
- Reported
- 6 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 22 Jan 2024 | Recall initiated by company | |
| 29 Feb 2024 | Classified by FDA | +38 days |
| 6 Mar 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
Product as listed by the FDA
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12
Where it was distributed
Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.
Questions about this recall
Is LINK BiMobile Dual Mobility System E-Poly Liner for Head Shell- Indicated for patients recalled?
Yes. Waldemar Link GmbH & Co. KG (Mfg Site) recalled LINK BiMobile Dual Mobility System E-Poly Liner for Head Shell- Indicated for patients on 22 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1219-2024.
Why was it recalled?
Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
Which lots are affected?
UDI-DI: 04026575230747 Lot Numbers: 2334253, 2325426
Where was it sold?
Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.
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 Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 | 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 | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |