CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
Reported: August 1, 2018 Initiated: June 21, 2018 #Z-2521-2018
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.
Details
- Recalling Firm
- DePuy Orthopaedics, Inc.
- Units Affected
- N/A
- 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511. Recalled by DePuy Orthopaedics, Inc.. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 1, 2018. Severity: Moderate. Recall number: Z-2521-2018.
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