Device product

MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination

Z-2641-2023

July 14, 2023

Class II

Product summary

Firm: Waldemar Link GmbH & Co. KG (Mfg Site)
Event: Event 92807
Status: Ongoing
Classification: Class II
Quantity: 8 units
Official record key: device-enforcement:Z-2641-2023

Official wording

Reason: Product is labeled with incorrect offset.

Code information: 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 pattern: Domestic distribution to AL, NJ, NV.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Product is labeled with incorrect offset.