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.
What this means for you
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)
- Hazard
- mis-labeling
- incorrect-specification
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
Distributed in 3 states:
- AL
- NJ
- NV
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