Z-2521-2018 Class II Terminated
FDA device recall Z-2521-2018 was initiated by DePuy Orthopaedics, Inc. on Jun 21, 2018 and is designated Class II. Reason for recall: Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical… The recall status is terminated (terminated Apr 6, 2020).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 1, 2018
- Initiation Date
- Jun 21, 2018
- Termination Date
- Apr 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
Reason for Recall
Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.
Distribution Pattern
Accounts in AL, CA, CO, GA< IL, LA, ME, NC, NH, NY, OR, TX, UT, and WA. Foreign distribution to Belgium, Croatia, Cyprus, Denmark, Germany, Indonesia, Korea, Sweden, and Tunisia.
Code Information
5307603 5300997
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2521-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026