RecallRadar

FDA Device recall Z-2641-2023

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

On 2023-10-04 the FDA classified a Class II recall of MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination by Waldemar Link And Kg Mfg Site, citing product is labeled with incorrect offset.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2641-2023
ClassificationClass II
Statusongoing
Initiated2023-07-14
Published2023-10-04
Last updated2026-09-13 11:56 UTC
CompanyWaldemar Link And Kg Mfg Site
DistributionAL, NJ, NV

Product

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

Reason

Product is labeled with incorrect offset.

Identifiers

code_infoUDI-DI: 04026575182329 Item Number: 183-610/05 Lots: 210526/0781; 210526/0777; 210526/0779; 210526/0771; 210526/0772; 210526/0783; 210526/0784; 210526/0778

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2641-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.