Reported Aug 1, 2018 · Terminated
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
- Lot codes and dates
- 5307603 5300997
- Amount recalled
- N/A
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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