Recall Z-2521-2018 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
DePuy Orthopaedics, Inc.
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
| Date | Jun 21, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | On June 21, 2018, the firm issued an Urgent Information: US Recall Notice via email to affected customers. Medical professionals were asked to do the following: " Cease using the affected components immediately. " Immediately return unused affected units: Medical facilities are to determine if any of the recalled components are still on hand, and return affected devices immediately to their DePuy Sales Consultant or return them to DePuy for credit following normal purchasing procedures. Reconciliation forms should be faxed to 574-371-4939. " Reconciliation Form: Complete the Reconciliation |
| Distribution | 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. |
| FDA record | Open on fda.gov |