CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report
Corail Coxa Vara High Offset Stem Collared Size recalled
DePuy Orthopaedics is recalling Corail Coxa Vara High Offset Stem Collared Size 9, distributed nationwide in the US. The recall was initiated on 12 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0593-2018
- FDA event ID
- 79024
- Recalling firm
- DePuy Orthopaedics, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jul 2017
- FDA classified
- 12 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 12 Jul 2017 | Recall initiated by company | |
| 12 Feb 2018 | Classified by FDA | +215 days |
| 21 Feb 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
Where it was distributed
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.
Questions about this recall
Is Corail Coxa Vara High Offset Stem Collared Size 9 recalled?
Yes. DePuy Orthopaedics recalled Corail Coxa Vara High Offset Stem Collared Size 9 on 12 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-0593-2018.
Why was it recalled?
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).
Which lots are affected?
Part No. 3L93709 and Lot No. 5291990
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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