DePuy Synthes Orthopedic Instruments Recalled for Quality System Violations
DePuy Orthopaedics is recalling 345 orthopedic instruments modified by U.S. distributors because they were made outside quality system regulations, potentially compromising safety and effectiveness.
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: The recall involves a risk-of-harm product (medical device) where the safety and effectiveness cannot be assured due to regulatory violations, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 345 units of various orthopedic instruments that were modified by U.S. distributors. These instruments are used in various orthopedic procedures. The recall is due to the fact that the products were made outside of Quality System Regulation and potentially outside of premarket submission requirements (510k/PMA) for certain devices.
The agency notes that the safety or effectiveness of these devices cannot be assured. The affected units were distributed nationwide to the following states: Arizona, California, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Pennsylvania, and Virginia.
Healthcare facilities and distributors should stop using these instruments and contact DePuy Orthopaedics for instructions on return or replacement. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 345
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)
- Unknown
Distribution
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