DePuy CORAIL Femoral Stems Recalled Due to Incorrect Size Labeling
DePuy Orthopaedics is recalling two lots of CORAIL femoral stems labeled as Size 11 but actually Size 12 due to fit and mechanical risks.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (improper fit, fracture) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling two lots of CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511. The recall is due to a labeling error where the devices were marked as Size 11 but are actually Size 12.
The incorrect sizing may lead to poor joint mechanics, improper fit, loosening, or the need for additional surgical procedures to correct the issue. There is also a risk of intraoperative fracture, which could result in surgical delays and further procedures.
The affected lots are identified by codes 5307603 and 5300997. Distribution included accounts in Alabama, California, Colorado, Georgia, Illinois, Louisiana, Maine, North Carolina, New Hampshire, New York, Oregon, Texas, Utah, and Washington, as well as foreign distribution to Belgium, Croatia, Cyprus, Denmark, Germany, Indonesia, Korea, Sweden, and Tunisia. Healthcare providers should stop using these devices and contact the manufacturer for instructions.
The recalled product
- Product
- CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
- Manufacturer
- DePuy Orthopaedics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 5307603 5300997
Distribution
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