FDA Device recall Z-0802-2021
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 1…
- FDA Device
- Class II
- terminated
- Published 2021-01-13
On 2021-01-13 the FDA classified a Class II recall of Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 1… by Depuy Orthopaedics, citing 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 prot….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0802-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-15 |
| Published | 2021-01-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Lots 8591362 8591361 8591363 8592831 8594131 8593445 8593245 8592830 8596365 8594132 8594461 8596511 859637…Lots 8591362 8591361 8591363 8592831 8594131 8593445 8593245 8592830 8596365 8594132 8594461 8596511 8596371 8596372 8596369 8596495 8596510 8597345 8597338 8597347 8597351 8594149 8597340 8597339 8597465 8592165 8596366 8597466 8592829 8597892 8598955 8597898 8598954 8597341 8597346 8597463 8598953 8599439 8594152 8598421 8597342 8599734 8594155 8598956 8599793 8599801 8599791 8599800 8599448 8599792 8599447 8598945 8599657 8599655 8599790 8599669 8599656 8599894 8600091 8599895 8592317 8599668 8599902 8599803 8599796 8600146 8600148 8600173 8600147 8599665 8599797 8599667 8599664 8599670 8600170 8599663 8599798 8601003 8599899 8601399 8601004 8600169 8601641 8599666 8600172 8601411 8601005 8601634 8601656 8601633 8601644 8601002 8601635 8602769 8600174 8601409 8602929 8599659 8602837 8602915 8602914 8602844 8602930 8602836 8602835 8602838 8602833 8602818 8602839 8602779 86028 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0802-2021%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.