Pinnacle Cups — Class II medical device recall Z-0802-2021
Terminated recall by DePuy Orthopaedics, Inc., reported 2021-01-13, distributed nationwide. Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex
| Recall number | Z-0802-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2020-12-15 |
| Classified | 2021-01-07 |
| Reported by FDA | 2021-01-13 |
| Terminated | 2023-11-14 |
| Distributed | Nationwide (US) |
| Lot numbers | 8591361, 8591362, 8591363, 8592165, 8592317, 8592829, 8592830, 8592831, 8593245, 8593445, 8594131, 8594132, 8594149, 8594152, 8594155, 8594461, 8596365, 8596366, 8596369, 8596371, 8596372, 8596495, 8596510, 8596511, 8597338, 8597339, 8597340, 8597341, 8597342, 8597345, 8597346, 8597347, 8597351, 8597463, 8597465, 8597466, 8597892, 8597898, 8598421, 8598945 and 460 more |
| Model 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 and 13 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0802-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.