MobileLink Acetabular Cup System Recalled for Incorrect Offset Labeling
Waldemar Link is recalling 8 units of the MobileLink Acetabular Cup System due to labeling with an incorrect offset specification. The mislabeling could affect proper surgical placement of this orthopedic implant.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving labeling of a high-risk orthopedic implant. While no injuries or illnesses have been reported, the incorrect offset labeling presents a documented risk that could result in improper implant placement and biomechanical complications.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling 8 units of the MobileLink Acetabular Cup System (Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination). The recalled units are labeled with an incorrect offset specification.
The incorrect labeling could result in improper implant selection or placement during hip replacement surgery. An acetabular cup implanted with the wrong offset may cause biomechanical problems requiring revision surgery.
The recall affects units distributed domestically to Alabama, New Jersey, and Nevada. The specific lot numbers are 210526/0781, 210526/0777, 210526/0779, 210526/0771, 210526/0772, 210526/0783, 210526/0784, and 210526/0778.
Surgeons and healthcare facilities with these units should verify the correct offset specification before implantation and contact Waldemar Link with questions.
The recalled product
- Product
- MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- UDI-DI: 04026575182329 Item Number: 183-610/05 Lots: 210526/0781
- 210526/0777
- 210526/0779
- 210526/0771
- 210526/0772
- 210526/0783
- 210526/0784
- 210526/0778
Distribution
Related recalls
Same manufacturer · Waldemar Link GmbH & Co. KG (Mfg Site)
See all →- HighWaldemar Link Recalls Endo-Model Tibial Plateau Replacement Sets
FDA (Devices) · 2026-08-19
- ModerateEmbrace standard drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- ModerateEmbrace shoulder drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- HighLink Endo-Model plateau 15-0027/15 recalled over screw bushing fracture
FDA (Devices) · 2026-03-18
- HighLink Endo-Model SL component 16-2840/05 recalled over bushing fracture
FDA (Devices) · 2026-03-18
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- ModerateHip Reconstruction System Component Mislabeled for Size
FDA (Devices) · 2025-01-01
- ModerateWaldemar Link BiMobile UHMWPE Liner Recalled for Incorrect Internal Labeling
FDA (Devices) · 2019-01-23
- HighG7 Acetabular Liner Recalled for Size and Label Discrepancy
FDA (Devices) · 2023-03-29
- ModerateWaldemar Link Recalls BiMobile UHMWPE Liners Due to Labeling Errors
FDA (Devices) · 2019-01-23
- ModerateOMNI Hip System Acetabular Inserts Recalled for Improper Labeling
FDA (Devices) · 2018-08-01
- HighHip Implant Component Mislabeled With Wrong Insert Type on Packaging
FDA (Devices) · 2024-03-06