CORAIL Cementless Femoral Stem HA Coated Standard Size 11 — Class II medical device recall Z-2521-2018
Terminated recall by DePuy Orthopaedics, Inc., reported 2018-08-01, distributed in AL, CA, CO, GA, IL, LA, ME, NC…. Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effec
| Recall number | Z-2521-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-06-21 |
| Classified | 2018-07-20 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2020-04-06 |
| Distributed | AL, CA, CO, GA, IL, LA, ME, NC, NH, NY, OR, TX, UT, WA |
| Countries outside the US | BE, CY, DE, DK, HR, ID, KR, SE, TN |
| Reason classes | labeling, device malfunction |
| Model numbers | 3L92511 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2521-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.