Food, drugs, devices › DePuy Orthopaedics, Inc.
Device recall: CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
FDA enforcement event 79024 is a device recall by DePuy Orthopaedics, Inc. of Warsaw, IN, initiated 12 Jul 2017 and classified Class II, with 2 product records.
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 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 20 May 2019. 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
"Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130)."
Distribution
"Nationally; US Consignees for this recall are the affected are US Distributors and US Medical Facilities (Hospitals/User Facilities) that may have purchased, used, or received the affected device."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0593-2018 | CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 | 21 Units | Class II | Terminated | 21 Feb 2018 |
| Z-0594-2018 | CORAIL HIGH OFFSET STEM Collarless SIZE 14 | 19 | Class II | Terminated | 21 Feb 2018 |
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: "Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130)."
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: "Nationally; US Consignees for this recall are the affected are US Distributors and US Medical Facilities (Hospitals/User Facilities) that may have purchased, used, or received the affected device."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 May 2019. "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.