Food, drugs, devices › DePuy Orthopaedics, Inc.
Device recall: Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 12
DePuy Orthopaedics, Inc. (Warsaw, IN) initiated this device recall on 15 Dec 2020; FDA lists 1 product record under event 86946, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 14 Nov 2023. Initiation: voluntary: firm initiated. DePuy Orthopaedics, Inc. has 59 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
DePuy Orthopaedics, Inc., Warsaw, IN.
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."
Distribution
"Worldwide distribution - US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0802-2021 | 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… | 14161 lots (10 units/lot) | Class II | Terminated | 13 Jan 2021 |
Context
Other enforcement events for DePuy Orthopaedics, Inc.
All 59 events for DePuy Orthopaedics, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Nov 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.