Hip replacement surgical kits recalled by DeRoyal Industries
DeRoyal Industries Inc has recalled 19 anterior approach total hip replacement surgical kits distributed across 23 U.S. states. This Class II recall was initiated voluntarily by the manufacturer.
What this means for you
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: Class II medical device recall of a surgical implant with no reported illnesses or injuries in available source information. Surgical implants that require recall present an inherent risk of harm to patients.
Plain-English summary
DeRoyal Industries Inc is recalling 19 anterior approach total hip replacement surgical kits, model REF 89-10612.01. These kits contain Lot 55970901 (expiration date 11/1/2023) and Lot 57591032 (expiration date 1/1/2024).
The affected kits were distributed to healthcare facilities in 23 U.S. states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi. The recall remains ongoing.
The FDA has classified this as a Class II recall, indicating potential health risks associated with the devices. DeRoyal Industries Inc initiated this recall voluntarily.
Hospitals, surgical centers, and other healthcare facilities that received these kits should immediately contact DeRoyal Industries Inc for instructions on handling the affected products.
The recalled product
- Product
- DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- surgical-implant-defect
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 (2)
- Lot Numbers: Lot 55970901 exp 11/1/2023
- Lot 57591032 exp 1/1/2024
Distribution
Distribution scope not specified by the agency.
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