CORAIL Cementless Femoral Stem HA Coated Standard recall
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
Why was CORAIL Cementless Femoral Stem HA Coated Standard 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
5307603 5300997
- Product
- CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 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.
- Recall date
- August 1, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)