Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of "cross-threading". If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup.

On December 15, 2020, the firm distributed Urgent Medical Device Correction letters to customers. The letter informed customers that there is a potential for an oversized "minor diameter" on certain Pinnacle Cup devices. The correction is intended to advise physicians of the oversize condition of the hole in the cup, which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of cross-threading. This may occur if the Apex HE is manipulated or toggled while threading it through the hole of certain Pinnacle Cup devices. If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup. Customers were asked to review the information in the letter and complete and return the included customer response form. If any of the affected products have been forwarded to another facility, please contact that facility and provide a copy of the recall notification to the relevant personnel. Post a copy of the notice in a visible area for awareness. If you have any questions, please contact your Sales Consultant.